[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486163":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":87,"collaborators":89,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":10,"eligibilityCriteria":104,"healthyVolunteers":101,"sex":105,"minAge":106,"maxAge":10,"enrollmentInfo":107,"targetDuration":10,"studyType":110,"phases":10,"briefSummary":111,"conditions":112,"keywords":122,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient population",null,"All consecutive patients (\\> 18 years) undergoing a tru-cut biopsy at the participating centers during the study periof will be eligible for inclusion in the study.\n\nAll biopsies will be performed by trained operators in gynecologic ultrasound and tru-cut biopsies. Tissue samples will be assessed by experienced pathologists, dedicated in gynecologic oncology. Data will be collected by reviewing patients' electronic medical file including data concerning further treatment-strategy and pathology reports. Patients' level of pain and overall experience will be assessed by an independent investigator not present during biopsy. This will be performed from 0-72h after the biopsy using a numeric rating scale (0-100). Safety and complication-rate will be assessed by both using the collected data and via postprocedural assessment and by phone after six weeks. Inclusion and exclusion criteria can be found elsewhere.",[13],"Procedure: Ultrasound guided tru-cut biopsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Ultrasound guided tru-cut biopsy","Tru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Wouter Froyman, MD, PHD","CONTACT","+3216344202","wouter.froyman@uzleuven.be",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Stefan Timmerman, MD","stefan.timmerman@uzleuven.be",[30,45,59,73],{"facility":31,"status":32,"city":33,"state":10,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"UZ Leuven","RECRUITING","Leuven","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.70093,50.87959,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":24,"phoneExt":10,"email":25},"Wouter Froyman, MD, PhD",{"facility":46,"status":47,"city":48,"state":10,"zip":10,"country":49,"countryCode":10,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"First Faculty of Medicine, Charles University","NOT_YET_RECRUITING","Prague","Czechia",{"type":37,"coordinates":51},[52,53],14.42076,50.08804,{"lat":53,"lon":52},[56],{"name":57,"role":23,"phone":10,"phoneExt":10,"email":58},"Daniela Fischerova, MD, PHD","Daniela.Fischerova@vfn.cz",{"facility":60,"status":47,"city":61,"state":10,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Fondazione Policlinico Universitario A. Gemelli, IRCSS","Rome","Italy","IT",{"type":37,"coordinates":65},[66,67],12.51133,41.89193,{"lat":67,"lon":66},[70],{"name":71,"role":23,"phone":10,"phoneExt":10,"email":72},"Antonia Carla Testa, MD, PHD","antoniacarla.testa@unicatt.it",{"facility":74,"status":47,"city":75,"state":10,"zip":10,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Department of Clinical Science and Education, Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset","Stockholm","Sweden","SE",{"type":37,"coordinates":79},[80,81],18.06871,59.32938,{"lat":81,"lon":80},[84],{"name":85,"role":23,"phone":10,"phoneExt":10,"email":86},"Elisabeth Epstein, MD, PHD","elisabeth.epstein@regionstockholm.se",{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[90,93,95,97],{"name":91,"class":92},"UZ Leuven, Leuven, Belgium","UNKNOWN",{"name":94,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":96,"class":6},"Charles University, Czech Republic",{"name":98,"class":92},"Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.","100486163","ultrasound-guided-tru-cut-biopsy-in-pelvic-masses-100486163",false,"NCT05610501","Ultrasound-guided Tru-Cut Biopsy in Pelvic Masses.","Inclusion Criteria:\n\n* 1\\. Following lesion criteria applicable for biopsy:\n\n  1. Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)\n  2. Solid component present (purely cystic lesions excluded)\n\n     2\\. Biopsy for research purposes, the following is applicable: Patients with a gynecological tumor eligible for participation in academic or commercial clinical trials requesting a biopsy for translational research. For the current study, which is observational, we do not intend to take additional biopsies outside routine clinical practice, but only biopsies requested for participation in other (interventional) studies on systemic treatment in gynecologic oncology.\n\n     3\\. In case of a diagnostic biopsy, one of the following inclusion criteria should be applicable:\n\n  \u003C!-- -->\n\n  1. Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and\n\n     * Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing\n     * Are invalid candidates for primary (radical) surgery due to the extensive disease-spread according to imaging and\u002For diagnostic laparoscopy\n  2. Suspicious primary disseminated NON-gynecologic tumor (tumor itself or metastasis)\n  3. Patients with possible recurrence of a gynecological tumor (cervix, myometrial, endometrial, ovarian etc), where histological confirmation of disease recurrence is necessary before the possibility to start a surgical or systemic intervention.\n  4. Patients with possible recurrence of a presumably non-gynecological tumor, where histological confirmation of disease recurrence is necessary before start of treatment.\n  5. Solitary tumor of unknown histology localized in vaginal wall, parametria, retroperitoneum or uterine wall and can be punctured without spilling in abdominal cavity.\n\nExclusion Criteria:\n\n\\- 1. Patients \\\u003C 18 years 2. Clotting defect or anticoagulation therapy, precluding a safe biopsy even with adapted therapy regimen.\n\n3\\. Vaginal or pelvic infection 4. Poor performance status contraindicating any specific oncologic treatment","FEMALE","18 Years",{"count":108,"type":109},200,"ESTIMATED","OBSERVATIONAL","In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.\n\nThis clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.",[113,114,115,116,117,118,119,120,121],"Pelvic Cancer","Ovarian Cancer","Cervical Cancer","Uterus Cancer","Endometrial Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Sarcoma Uterus","Metastatic Cancer",[123,124,125,126,127],"Tru-cut","Ultrasound","Pelvic mass","Ovarian cancer","Gynaecologic oncology","2024-07-01",{"date":130,"type":131},"2024-07-03","ACTUAL",{"date":133,"type":131},"2021-05-01",{"date":135,"type":109},"2025-04-30",{"name":5,"class":6},4]