[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578812":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":37,"studyPopulation":38,"armGroups":34,"interventions":39,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":78,"collaborators":34,"id":81,"slug":34,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":34,"enrollmentInfo":90,"targetDuration":34,"studyType":93,"phases":34,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":34,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"General University Hospital, Prague","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"The adequacy of samples obtained by TCB for histopathological examination (in %)","1\\. The adequacy means the ability to determine the type of tumor (in %)","First data 31st of June 2025, definitive data 31st of January 2026",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"The adequacy of samples obtained by TCB for next-generation sequencing examination (in %)","2\\. Adequacy of samples obtained by TCB for next-generation sequencing examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.",{"measure":18,"description":19,"timeFrame":12},"The adequacy of samples obtained by TCB for immunohistochemistry examination (in %)","3\\. Adequacy of samples obtained by TCB for immunohistochemistry examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.",{"measure":21,"description":22,"timeFrame":12},"The adequacy of samples obtained by TCB for immunologic examination (in %)","4\\. Adequacy of samples obtained by TCB for immunologic examination (in %) Adequacy is defined as the ability to determine the complex classification of the tumor.",[24,27,30],{"measure":25,"description":26,"timeFrame":12},"1. To evaluate which factors affect the primary and secondary endpoints 2. To evaluate the overall safety of TCB (in %) 3. To evaluate the overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)","5\\. Evaluation of factors affecting the primary and secondary endpoints\n\nIncludes tumor origin, size, presence of ascites, BMI, biopsy site, biopsy approach, disease status, and previous treatment modalities.",{"measure":28,"description":29,"timeFrame":12},"Overall safety of TCB (in %)","6\\. Overall safety of TCB (in %)",{"measure":31,"description":32,"timeFrame":12},"Overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)","7\\. Overall accuracy of TCB for complex classification of pelvic and abdominal tumors (in %)",{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":35,"timePerspective":36,"maskingInfo":34},null,"COHORT","PROSPECTIVE","The primary endpoint is represented by the assessment of adequacy, accuracy and safety of the procedure in prospective settings. The secondary endpoint is to evaluate feasibility of immunohistochemistry (IHC), next generation sequencing (NGS) and tumor immunology in obtained samples by TCB and to assess the alterations of these tumor characteristics in relation to the treatment. The additional endpoint includes the effect of several variables (e.g. tumor origin, size of the tumor, presence of ascites, body mass index (BMI), biopsy site, biopsy approach - transvaginal, transrectal vs. transabdominal, status of the disease - the first diagnosis, the first and other recurrence or progression and previous treatment modality - chemotherapy, anti-angiogenic therapy, PARP inhibitor therapy, hormonal therapy, radiotherapy) on the outcome of the procedure (adequacy, accuracy and safety).\n\nAll patients indicated for tru-cut biopsy (including advanced stages of ovarian, endometrial or cervical cancers) in Gynecologic Oncology Center of the General University Hospital from February 2024 to January 2026 will be recruited. Furthermore, all patients with suspicious recurrence or progression of already known gynecologic malignancy based on the imaging methods will be recruited. The duration of recruitment is 3 years, and we expect 250 patients enrolled into the trial. Data will be assessed in relation to the patient characteristics, tumor\u002Flesion characteristics, procedure specifications, histopathological characteristics and IHC\u002FNGS\u002Fimmunological characteristics, consequent biopsy\u002Fsurgery and final histopathological results. All adverse events will be recorded. Moreover, patient related outcomes will be recorded within 72 hours after the procedure.\n\nThis prospective study could support our hypothesis that TCB is feasible and safe procedure with high adequacy and accuracy rate. It enables to get appropriate outcomes of IHC, NGS and immunology preoperatively. We expect that TCB is applicable and efficient in majority of recurrences\u002Fdisease progressions, so it can be considered suitable technique for de novo biopsy. It can help us show the alterations of tumor characteristics after the previous treatment and can be used to select appropriate targeted therapy.","Women with abdominopelvic tumor",[40],{"type":41,"name":42,"description":43,"armGroupLabels":34,"otherNames":44},"PROCEDURE","tru-cut biopsy","needle biopsy from the tumor",[45],"core-cut biopsy",[47],{"name":48,"affiliation":49,"role":50},"David Cibula, prof.","Department of Gynecology, Obstetrics and Neonatology","STUDY_CHAIR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":34,"email":56},"Renata Poncová, MD.","CONTACT","+420731573737","poncova.renata@gmail.com",{"name":58,"role":54,"phone":34,"phoneExt":34,"email":59},"Filip Frühauf, MD.","filip.fruehauf@vfn.cz",[61],{"facility":62,"status":63,"city":64,"state":34,"zip":65,"country":66,"countryCode":34,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Department of Gynecology, Obstetrics and Neonatology of First Faculty of Medicine and General University Hospital in Prague","RECRUITING","Prague","12800","Czechia",{"type":68,"coordinates":69},"Point",[70,71],14.42076,50.08804,{"lat":71,"lon":70},[74,76],{"name":75,"role":54,"phone":55,"phoneExt":34,"email":56},"Renata Poncová",{"name":77,"role":54,"phone":34,"phoneExt":34,"email":59},"Filip Frühauf",{"type":79,"investigatorFullName":75,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100578812",false,"NCT06816160","TRU-Cut Biopsy in Tumor cHaracterisation","Tru-cut Biopsy in Tumor Characterisation","TRUTH","Inclusion Criteria: Presence of a pelvic\u002Fabdominal lesion with suspicion of malignancy:\n\n1. new diagnosis of a presumed gynecologic tumor\n2. suspicious recurrence or progression of a known gynecologic malignancy\n3. pelvic\u002Fabdominal spread or recurrence of a non-gynecologic tumor (primary tumor or metastasis)\n4. pelvic\u002Fabdominal spread of a tumor of unknown origin 2. Age ≥18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status grade \\\u003C3 4. Not pregnant 5. Signed informed consent form\n\nExclusion Criteria:\n\n1. Considered by the investigator to be unsuitable for any treatment\n2. Early stage disease\n3. Age \\\u003C18 years","FEMALE","18 Years",{"count":91,"type":92},250,"ESTIMATED","OBSERVATIONAL","Tru-cut biopsy (TCB) is a minimally invasive method to get an adequate sample from the lesion in order to tailor the appropriate management avoiding unnecessary surgery. The aim of our trial is to evaluate the adequacy, accuracy and safety of the method related to the final histology as reference standard.",[96],"Tumor",[98,99,100,101,102,103],"tumor","biopsy","tru-cut","core-cut","cancer","pelvic tumor","2025-02-05",{"date":106,"type":107},"2025-02-10","ACTUAL",{"date":109,"type":107},"2024-02-01",{"date":111,"type":92},"2027-01-31",{"name":5,"class":6},1]