[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493862":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":31,"responsibleParty":87,"collaborators":89,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Centre Jean Perrin","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL",null,[13],"Biological: Blood sample",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Blood sample","The intervention consist in a blood sample that will be taken twice :\n\n* at the inclusion (before treatment)\n* 3 months after the radiochemotherapy in case of incomplete response (PET-CT)",[9],[21],{"name":22,"affiliation":5,"role":23},"Maureen BERNADACH, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Angeline GINZAC COUVÉ, PhD","CONTACT","0463663337","+33","angeline.ginzac@clermont.unicancer.fr",[32,50,65,76],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Centre Jean PERRIN","RECRUITING","Clermont-Ferrand","Puy-de-Dôme","63011","France",{"type":40,"coordinates":41},"Point",[42,43],3.08682,45.77969,{"lat":43,"lon":42},[46,48],{"name":47,"role":27,"phone":11,"phoneExt":11,"email":30},"Angeline GINZAC COUVÉ",{"name":49,"role":23,"phone":11,"phoneExt":11,"email":11},"Maureen BERNADACH, Dr",{"facility":51,"status":52,"city":53,"state":11,"zip":54,"country":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Centre Hospitalier Henri Mondor","NOT_YET_RECRUITING","Aurillac","15000",{"type":40,"coordinates":56},[57,58],2.43983,44.92539,{"lat":58,"lon":57},[61],{"name":62,"role":27,"phone":63,"phoneExt":11,"email":64},"Daniela BURLACU, MD","0471465656","D.burlacu@ch-aurillac.fr",{"facility":66,"status":34,"city":67,"state":11,"zip":11,"country":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Hôpital de la Croix-Rousse","Lyon",{"type":40,"coordinates":69},[70,71],4.84789,45.74906,{"lat":71,"lon":70},[74],{"name":75,"role":23,"phone":11,"phoneExt":11,"email":11},"Philippe CÉRUSE, Pr",{"facility":77,"status":34,"city":78,"state":11,"zip":11,"country":38,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU de Saint-Étienne","Saint-Etienne",{"type":40,"coordinates":80},[81,82],4.39,45.43389,{"lat":82,"lon":81},[85],{"name":86,"role":23,"phone":11,"phoneExt":11,"email":11},"Yann LELONGE, Dr",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[90],{"name":91,"class":6},"GIRCI Auvergne Rhone-Alpes","100493862",false,"NCT05710679","Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer","NeckTAR","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years\n* Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement\n* squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)\n* Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary\n* Availability of FFPE samples prior to treatment initiation\n* Detection of circulating DNA in the initial blood sample\n* Obtaining informed consent from the patient\n* Affiliation to the French social security system\n\nExclusion Criteria:\n\n* Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer\n* Treatment by exclusive radiotherapy\n* Contraindication to cervical lymph node dissection\n* Metastatic disease (stage IVc)\n* Previous treatment for head and neck cancer\n* History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)\n* Pregnant or breastfeeding woman\n* Patient under guardianship or curators\n* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment","ALL","18 Years","80 Years",{"count":102,"type":103},63,"ESTIMATED","INTERVENTIONAL",[106],"NA","Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.\n\n18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET\u002FCT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.\n\nCirculating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.\n\nThis is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.",[109],"Locally Advanced Head and Neck Carcinoma","2026-05-21",{"date":112,"type":113},"2026-05-26","ACTUAL",{"date":115,"type":113},"2024-01-17",{"date":117,"type":103},"2031-07",{"name":5,"class":6},4]