[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharynx-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharynx-squamous-cell-carcinoma":218},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,76,111,138,163,194],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100643980",false,"NCT07667296","APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Open-Label Phase 3 Study of APG-157 as Neoadjuvant Therapy or as Induction and Maintenance Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\nCohort A (Resectable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity or oropharynx.\n3. Resectable disease appropriate for curative-intent surgery.\n4. Stage III-IVA disease according to AJCC criteria:\n\n   * Oropharynx, p16-positive: Stage III (T4, N0-N3, M0)\n   * Oropharynx, p16-negative: Stage III or IVa (T3-T4, N0-N2, M0)\n   * Oral cavity: Stage III or IVa (T3-T4, N0-N2, M0)\n5. Objectively medically ineligible for perioperative pembrolizumab according to protocol-defined objective criteria.\n6. HPV\u002Fp16 testing available for stratification.\n7. Measurable or evaluable disease.\n8. Life expectancy ≥12 months.\n9. ECOG Performance Status ≤2.\n10. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n11. Ability to comply with study procedures.\n\nCohort B (Unresectable \u002F Medically Inoperable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated LA-HNSCC of the oropharynx. Disease not suitable for curative-intent surgery.\n3. Stage III-IVA disease according to AJCC criteria:\n\n   * p16-positive Stage III (T4, N0-N3, M0) with \\>10 pack-year smoking history\n   * p16-negative Stage III or IVa (T3-T4, N0-N2, M0)\n4. HPV\u002Fp16 testing available for stratification.\n5. Presence of evaluable tumor burden.\n6. Eligible to receive definitive chemoradiotherapy.\n7. Life expectancy ≥12 months.\n8. ECOG Performance Status ≤2.\n9. Adequate organ function.\n10. Contraception requirements met.\n11. Ability to comply with study procedures.\n\nExclusion Criteria\n\nCohort A Specific:\n\n* Stage I-II disease\n* Stage IVb or Ivc disease\n* T4b unresectable disease\n* N3 disease where applicable\n* Medically eligible for perioperative pembrolizumab\n\nCohort B Specific:\n\n* Stage I-II disease\n* Disease not appropriate for curative-intent CRT\n* Active autoimmune disease requiring systemic therapy\n* Prior solid organ or allogeneic stem cell transplant\n* Ongoing immunosuppression \\>10 mg\u002Fday prednisone equivalent\n\nCommon Exclusion Criteria:\n\n* Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.\n* Prior treatment for current head and neck squamous cell carcinoma.\n* Prior malignancy unless protocol exceptions met\n* Distant metastatic disease\n* Live vaccine within 30 days\n* Known hypersensitivity to APG-157 or its components.\n* Unresolved clinically significant toxicity\n* Recent participation in another investigational study\n* Active uncontrolled infection\n* Significant uncontrolled cardiovascular disease\n* Pregnancy or breastfeeding.\n* QTcF \\>500 msec or congenital long QT syndrome\n* Any condition compromising safety, compliance, or study interpretation\n\nRandomization ratio: 1:1 within each cohort\n\nStratification Factors:\n\nCohort A:\n\n* HPV\u002Fp16 status,\n* Planned platinum strategy,\n* PD-L1 CPS category\n\nCohort B:\n\n* HPV\u002Fp16 status\n* Planned platinum strategy\n* Geographic region.","ALL","18 Years",{"count":18,"type":19},826,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Two independently powered cohorts are enrolled based on treatment pathway. Cohort A evaluates APG-157 administered as neoadjuvant therapy before curative-intent surgery in participants with resectable oral cavity or oropharyngeal cancer who are medically ineligible for perioperative pembrolizumab. Cohort B evaluates APG-157 administered as induction therapy before definitive chemoradiotherapy and as maintenance therapy after chemoradiotherapy in participants with unresectable or medically inoperable disease. Participants are randomized 1:1 within each cohort to receive APG-157-based treatment or standard-of-care therapy. The primary hypothesis is that APG-157 given before definitive surgery followed by (chemo)radiotherapy improves event-free survival (EFS) compared to surgery and adjuvant (chemo)radiotherapy alone (Cohort A), and that APG-157 given as induction therapy prior to definitive chemoradiotherapy (CRT) followed by maintenance APG-157 improves EFS compared to definitive CRT alone (Cohort B).",[25,26,27,28,29,30,31],"Head and Neck Cancer","Head and Neck (HNSCC)","Oropharyngeal","Oral Cavity","Oral Cavity Carcinoma","Oropharynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":19},"2026-07",{"date":40,"type":19},"2032-12",{"name":42,"class":43},"Aveta Biomics, Inc.","INDUSTRY",{"id":45,"slug":4,"hasResults":10,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100405868","NCT04564989","Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","Inclusion Criteria:\n\n* ≥ 18 years of age\n* T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)\n* Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary\n* No prior therapy\n* No evidence of distant metastatic disease\n* p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2\u002F3+) staining intensity\n* Planned for receipt of definitive cancer treatment\n* ECOG Performance Status 0-1\n* Patients must be deemed able to comply with the treatment plan and follow-up schedule.\n* Patients must provide study specific informed consent prior to study entry\n\nExclusion Criteria: All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:\n\n* Prior history of radiation therapy to the head and neck\n* Prior history of head and neck cancer.\n* Inadequate pre-treatment tissue sample for tumor genomic analyses",{"count":51,"type":19},220,"OBSERVATIONAL","The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.",[55,56,57,30],"Oropharyngeal Squamous Cell Carcinoma","Carcinoma, Squamous Cell","Head and Neck Squamous Cell Carcinoma",[59,60,61,62,63],"Human Papillomavirus","HPV","p16","Oropharynx","OPSCC","RECRUITING","2026-04-27",{"date":67,"type":36},"2026-04-28",{"date":69,"type":36},"2020-11-19",{"date":71,"type":19},"2033-11",{"name":73,"class":74},"UNC Lineberger Comprehensive Cancer Center","OTHER",3,{"id":77,"slug":4,"hasResults":10,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":84,"briefSummary":86,"conditions":87,"keywords":99,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":5},"100597801","NCT07063212","A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)","A Phase II Study of Sacituzumab Govitecan in Combination With Cetuximab in Patients With Recurrent Metastatic HNSCC That Has Progressed After First-Line Therapy","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck arising from the sinuses, nasal cavity, oral cavity, oropharynx, hypopharynx, and larynx. Other sites not listed will be subject to PI discretion.\n\n  * Advanced disease (Stage IV or M1 disease) not amenable to curative local therapy with surgery and\u002For radiation based approaches\n  * Progression on first line anti-PD(L)1 therapy with or without chemotherapy or as part of a combination in a clinical trial\n  * HPV status for oropharynx primary must be previously confirmed or can be performed on available archival or fresh biopsy via p16 immunohistochemistry or HPV specific testing via PCR or RNA ISH. Patients are able to enroll and initiate treatment so long as this is in progress. Exceptions may be made after discussion and review with P.I.\n  * Have measurable disease per RECIST v1.1 criteria. Tumor lesions situated in previously radiated area may be utilized if they are measurable and progression has been demonstrated in these lesions.\n* Male or female patients 18 years of age or older on the day of consent.\n* ECOG Performance Status of 0 to 1.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002Fdl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g\u002Fdl is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  o Serum creatinine \\\u003C 2.0 x upper limit of normal (ULN) or creatinine clearance (CCr)\n\n  ≥ 30 ml\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \\[(140 - age) x (wt in kg)\\] \\[(Serum Cr mg\u002Fdl) x (72)\\] CCr female = 0.85 x (CrCl male)\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Total bilirubin ≤ 1.5 × ULN (except for unconjugated hyperbilirubinemia or Gilbert's syndrome). Direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN.\n  * AST and ALT \\\u003C 2.5 x the upper limit of normal\n  * Albumin ≥ 3 g\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n* Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.\n* Female patients are eligible to participate if they are not pregnant, not breastfeeding and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential\n  * A woman of childbearing potential who agrees to use highly effective contraception from signing of the ICF through six months after the last study treatment administration.\n\nNotes:\n\ni. Female of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year. ii. Highly effective contraception methods include:\n\n* Total abstinence\n* Male or female sterilization\n* Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):\n\n  * Category 1: Use of oral, injected, or implanted hormonal methods of contraception.\n  * Category 2: Placement of an intrauterine device or intrauterine system.\n  * Category 3: Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n  * A female participant who is of childbearing potential must have a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test within 72 hours prior to the first administration of study treatment or be surgically\u002Fbiologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal. Note: Postmenopausal females are defined as those who are:\n* Age \\> 50 years with amenorrhea for ≥ 12 months.\n* Age ≤ 50 years with six months of spontaneous amenorrhea and follicle stimulating hormone level within postmenopausal range (\\> 40 mIU\u002FmL).\n\n  * Male patients must agree to use contraception and refrain from sperm and egg donation from the time period between signing of the ICF and through five months after the last dose of study drug\n  * The subject must provide voluntary study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients must not have received more than 2 prior line of systemic treatment (i.e. in the second or third line of treatment) in the recurrent\u002Fmetastatic setting.\n\n  o Ambiguity regarding lines of treatment a patient has received will be subject to PI review and approval.\n* Patients with previous severe infusion or allergic reactions to EGFR antibody based therapy that is deemed unsafe for re-challenge based on assessment by PI and\u002For consultation with allergy\u002Fimmunology.\n* Patients who have previously received topoisomerase I inhibitors for HNSCC\n* Patients who have a confirmed or suspected diagnosis (subject to P.I. discretion) of Gilbert's Syndrome\n* Have had a prior anti-cancer biologic agent, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.\n* Have not recovered (ie, ≤ Grade 1) from AEs due to a previously administered agent.\n\n  * Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are exceptions to this criterion and may qualify for the study.\n  * Note: If subjects underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study drug.\n  * Note: Subjects with Grade ≤ 2 immune-mediated toxicities (except colitis which must be recovered, \\\u003C Grade 1) related to immunotherapy and\u002For radiation treatment that are long lasting, but stable on treatment and not requiring agents that are excluded by this protocol may qualify for the study.\n* Patients with simultaneous primary cancers aside from HNSCC will be excluded unless otherwise approved by PI.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate for the malignancy treated at 5 years is estimated to be 90% or greater, unless otherwise approved by PI\n* Severe, active co-morbidity defined as the following:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute infection requiring intravenous therapy at the time of registration\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defect\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, no evidence of new or enlarging brain metastases and are taking ≤ 20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), immune-mediated colitis, or gastrointestinal (GI) perforation within 6 months of C1D1.\n* Known acquired immunodeficiency syndrome due to untreated\u002Fpoorly controlled human immunodeficiency virus. Other diagnosed immunodeficiency syndromes or disorders will require the review and approval of the site PI.\n* Positive test for hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (anti-HCV), indicating acute or chronic infection. Patients who test positive for anti-HCV but negative for HCV ribonucleic acid (RNA) are permitted to enroll.\n* Herbal remedies known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise between the PI and treating investigator.\n* Female patients who are pregnant, breastfeeding, or plan on becoming pregnant during the study.",{"count":83,"type":19},40,[85],"PHASE2","The purpose of this study to find out whether sacituzumab govitecan in combination with cetuximab is an effective and safe treatment approach for people with recurrent and\u002For metastatic head and neck squamous cell cancer (HNSCC).",[88,89,90,91,92,93,94,95,30,96,97,98],"Squamous Cell Carcinoma of Head and Neck","Sinus Cancer","Nasal Cavity Cancer","Oral Cavity Cancer","Oropharynx Cancer","Hypopharynx Cancer","Larynx Cancer","Oral Squamous Cell Carcinoma","Hypopharynx Squamous Cell Carcinoma","Larynx Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[88,89,90,91,92,93,94,95,30,96,97,98,100,101,102],"Sacituzumab Govitecan","25-094","Memorial Sloan Kettering Cancer Center","2026-02-17",{"date":105,"type":36},"2026-02-19",{"date":107,"type":36},"2025-07-02",{"date":109,"type":19},"2028-01-02",{"name":102,"class":74},{"id":112,"slug":4,"hasResults":10,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":20,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100522881","NCT06088381","Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)","SAVAL","Inclusion Criteria\n\n1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n2. Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET\u002FCT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET\u002FCT) with imaging within 60 days of enrollment?\n3. Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?\n4. Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board?\n5. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n6. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n7. Is the patient ≥ 18 years of age?\n8. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n9. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\nExclusion Criteria\n\n1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n2. Does the patient have distant metastasis?\n3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low\u002Fintermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n6. Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies?\n7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",{"count":119,"type":19},61,[85],"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment.\n\nThe goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.",[25,57,92,30,98],[124,25,92,125,126,127],"Transoral Robotic Surgery (TORS)","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","2025-11-05",{"date":130,"type":36},"2025-11-10",{"date":132,"type":36},"2024-03-07",{"date":134,"type":19},"2030-12-18",{"name":136,"class":74},"University of Maryland, Baltimore",5,{"id":139,"slug":4,"hasResults":10,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100483983","NCT05582122","SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers","SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers","SURVEILLE-HPV","Inclusion Criteria:\n\n1. Patient aged 18 years or over\n2. Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)\n3. Clinical stage T1-4, N0-3, M0 (stages I-III)\n4. Any tobacco status\n5. Life expectancy greater than 36 months\n6. Positive HPV16 Ct-DNA measured before curative anticancer treatment\n7. Treated by any curative treatment\n8. Complete response at 3 months after end of treatment, which means:\n\n   * Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or\n   * Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or\n   * Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1).\n9. Patient must be affiliated to a Social Security System (or equivalent)\n10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his\u002Fher written consent, a trusted person of his\u002Fher choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent.\n\nExclusion Criteria:\n\n1. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n2. Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has\u002Fhave been surgically cured.\n3. Any other HPV induced cancer within 5 years\n4. Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding\n5. Patient unwilling or unable to comply with the study protocol and follow-up schedule.\n6. Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication).\n7. Patient deprived of liberty or placed under protective custody or guardianship.",{"count":146,"type":19},420,[85],"SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures.\n\nHPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status.\n\nHPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS.\n\nThe number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA.\n\nIf confirmed, this new strategy could have several benefits including:\n\n* reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and\n* Identification of relapse at early stages (before the occurrence of symptoms)",[30],[151,152],"HPV16","CtDNA","2025-09-15",{"date":155,"type":36},"2025-09-19",{"date":157,"type":36},"2024-04-03",{"date":159,"type":19},"2031-04-01",{"name":161,"class":74},"UNICANCER",16,{"id":164,"slug":4,"hasResults":10,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":169,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100473931","NCT05451303","Detection of Oral and Throat Cancers Using OralViome Cancer Testing System","Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis","Inclusion Criteria\n\n* Signed Informed Consent obtained\n* 18 years and older\n* At a high risk of developing oral or throat cancer based on clinician's discretion\n\nExclusion Criteria\n\n* Pregnancy\n* Use of fertility enhancing medications",true,{"count":171,"type":19},475,"To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.",[95,30,174],"Premalignant Lesion",[176,177,178,179,180,181,182,183,184,60],"Viome","oral cancer","detection","OSCC","OPMD-B","OPMD-PM","OPMD","OPV","Tobacco","2025-01-27",{"date":187,"type":36},"2025-01-29",{"date":189,"type":36},"2022-05-27",{"date":191,"type":19},"2026-12",{"name":176,"class":43},1,{"id":195,"slug":4,"hasResults":10,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":201,"targetDuration":203,"studyType":52,"phases":4,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":193},"100489188","NCT05649865","Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)","Analysis of HPV DNA in Plasma in Patients With HPV-positive Oropharyngeal Squamous Cell Carcinoma - a Prospective Study of HPV DNA Levels for Treatment Response and Surveillance","MER-HPV","Inclusion Criteria:\n\n1. Only patients with an HPV-positive primary tumour will eventually be eligible for inclusion.\n\n   Non-detectable ctHPVDNA at diagnosis will not be a reason for exclusion.\n2. Age \\>18 years.\n3. Able to give informed consent.\n4. The patient will be treated with curative intent.\n\nExclusion Criteria:\n\nPatients with a short life expectancy, psychiatric or addictive disorders, or other medical conditions which might impair patient compliance may be excluded at the discretion of the investigator.",{"count":202,"type":19},150,"3 Years","The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV.\n\nThe main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment.\n\nThe participants will be asked to provide blood tests:\n\n1. before treatment\n2. weekly during the treatment\n3. on all scheduled follow-up appointments\n4. on all unplanned appointments where a relapse is suspected",[30],[207,208],"Human papilloma virus","circulating HPV DNA","2023-06-07",{"date":211,"type":36},"2023-06-08",{"date":213,"type":36},"2023-05-15",{"date":215,"type":19},"2028-05",{"name":217,"class":74},"Region Skane",""]