[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gestational-trophoblastic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gestational-trophoblastic-disease":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100542204","ask-questions-in-gynecologic-oncology-asq-gyo-100542204",false,"NCT06339827","ASk Questions in GYnecologic Oncology (ASQ-GYO)","ASk Questions in GYnecologic Oncology (ASQ-GYO): A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics","ASQ-GYO","Inclusion Criteria:\n\n* 18 years of age\n* Understands spoken and written English\n* Able to consent to study participation\n* Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, or vaginal cancer or Gestational Trophoblastic Disease) OR have imaging and\u002For laboratory findings highly concerning for a cancer diagnosis and have not seen a Gynecologic Oncologist\n\nExclusion Criteria:\n\n* pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)\n* History and\u002For imaging\u002Flaboratory findings more indicative of a non-cancer diagnosis\n* Previous treatment discussion with a Gynecologic Oncologist","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.",[27,28,29,30,31,32],"Ovarian Cancer","Endometrial Cancer","Cervical Cancer","Vulvar Cancer","Vaginal Cancer","Gestational Trophoblastic Disease","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2024-04-04",{"date":41,"type":21},"2028-05",{"name":43,"class":44},"Ira Winer","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100488071","phase-2-a-feasibility-window-study-of-pembrolizumab-prior-to-second-evacuation-for-post-molar-gestational-trophoblastic-neoplasia-100488071","NCT05635344","A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia","Inclusion Criteria:\n\n1. Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule.\n2. Age ≥18yrs\n3. Postmolar GTN defined as recurrence or persistence of histologically confirmed CHM after primary surgical evacuation with no intervening treatment.\n4. Postmolar GTN defined as plateau or rising human chorionic gonadotropin (hCG). Plateaued hCG is defined as four or more equivalent values of hCG over at least 3 weeks. Rising hCG is defined as two consecutive rises in hCG of 10% or greater over at least 2 weeks.\n5. hCG under 20,000 IU\u002FL\n6. Low risk disease as defined by the Federation of Obstetrics and Gynecology (FIGO) 2000 risk scoring criteria (score of 6 or less)\n7. No metastatic disease on chest X-ray.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n9. Disease present within the uterine cavity not within 5mm of the serosal surface.\n10. Adequate bone marrow reserve or organ function as defined by any one of the following parameters:\n\n    * Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002FL;\n    * Platelet count ≥ 100 x 10\\^9 \u002FL;\n    * Haemoglobin ≥ 9.0 g\u002FdL (may have been blood transfused)\n    * Creatinine clearance ≥ 30 ml\u002Fmin (Cockcroft-Gault formula)\n    * Serum bilirubin ≤ 1.5 x ULN\n    * AST\u002FALT ≤ 2.5 X ULN\n11. All patients must agree to a highly effective method of contraception, or to complete abstinence\\* for 1 year following second evacuation. This is standard practice following second evacuation of GTN because hCG levels rise in pregnancy thus masking a potential cancer recurrence\n\nExclusion Criteria:\n\n1. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 2 years or patients whose previous cancer treatment contraindicates this protocol therapy.\n2. Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage.\n3. Pregnant women.\n4. Uncontrolled vaginal bleeding.\n5. Administration of live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. History of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n8. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n9. History of Human Immunodeficiency Virus (HIV) infection.\n10. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n11. History of active TB (Bacillus Tuberculosis).\n12. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. History of allogenic tissue\u002Fsolid organ transplant.","FEMALE",{"count":54,"type":21},20,[56],"PHASE2","Gestational Trophoblastic Diseases (GTD) are a variety of rare, pregnancy related cell multiplication disorders of cells of the placenta which can range from pre-cancerous growths to more serious lesions that can spread to nearby tissues that can cause serious health issues.\n\nMost patients that develop GTD are diagnosed at the precancerous stage early in pregnancy and undergo surgical removal of the disease from the uterus. Around 15% of patients are not cured by surgical removal alone and need to undergo further treatment with chemotherapy or further surgery; of which roughly one-third of patients are cured with a second round of surgery alone.\n\nAnti-cancer treatment with chemotherapy carries many short- and long-term side effects that can negatively affect a person's quality of living. Finding less harmful anticancer therapies that can be paired with surgery is therefore of great benefit to patients with recurrent GTD.\n\nAn alternative is to pair surgery with another class of anticancer treatments, known as immunotherapies. Immunotherapy aims to encourage the bodies natural defences to fight the cancer cells.\n\nPembrolizumab, an immunotherapeutic agent which works by preventing cancer cells from hiding from the immune system; has been proven to be an extremely safe form of anticancer therapy and is an attractive alternative to more toxic chemotherapeutic agents.\n\nThe RESOLVE study aims to determine how feasible it is to deliver pre-surgical pembrolizumab to patients and determine if this is a desirable alternative; potentially leading to a larger more definitive study.\n\n20 patients will be recruited onto the study and will be evenly split into two arms:\n\n* 10 patients to receive second evacuation alone\n* 10 patients to receive single dose of Pembrolizumab followed by surgery All patients that take part in the study will be recruited from Charing Cross Hospital and will be followed up for a year after the date of their surgery.",[32,59,60],"Gestational Trophoblastic Neoplasia","Gestational Trophoblastic Tumor, Recurrent","2024-04-15",{"date":63,"type":37},"2024-04-17",{"date":65,"type":37},"2024-02-14",{"date":67,"type":21},"2026-08-01",{"name":69,"class":44},"Imperial College London",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":80,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100277557","the-french-national-reference-centre-of-gtd-100277557","NCT02892877","The French National Reference Centre of GTD","The French National Reference Centre of Gestational Trophoblastic Disease","French GTDC","Inclusion Criteria:\n\n* Patients are eligible if they have a histologically proven trophoblastic disease, or a diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG\n\nExclusion Criteria:\n\n* none",{"count":79,"type":21},25500,"18 Months","OBSERVATIONAL","The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by registering, monitoring and treating women with GTD since november 1999. The aim is to improve the management of trophoblastic disease in France.\n\nAbout 850 new cases are registered each year and 140 women treated, mostly with chemotherapy and surgery.\n\nThe center works as follow, based on a multidisciplinary approach. The policy is that patient remains followed by her local physician, but can be seen and treated in the Center at demand and that the registry is done on a voluntary basis.\n\nEach administrative french area has a local expert team (oncologist and gynaecologist) who is able to look after the patients with the help of the national reference center physicians based in Lyon.\n\n* Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of his patient, for an opinion, an advice or simply to report the case.\n* The center sends to the doctor the informed consent form to be signed by the patient, a registering form and information about pathology for patient and physician, and first guidelines based on initial pathology report.\n\nThe patient remains followed by her gynecologist, who stays her first interlocutor throughout the whole process and she goes to her local laboratory for hCG monitoring;\n\n* A letter is sent to the initial pathology laboratory that originally carried the diagnosis of molar pregnancy to require slide sending to the pathologist referral center (9 experts with a specific pathologist national network) that centrally review initial diagnosis.\n* In the mean time, the data manager collects weekly hCG values to establish a follow-up chart. The physician is regularly informed by mail of the hCG evolution.\n* The local physician is contacted in case of modification of the diagnosis by the pathologist expert. The center informs him about length and monitoring methodology.\n* Emails or letters are sent at each step of the management (at inclusion, at hCG negativation, and at the end of hCG follow-up).\n* In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician is immediately contacted by phone or email by referent gynaecologist. A complete work up including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest radiography if pulmonary nodules are present and brain MRI, is planned to determine the adequate treatment.\n\nVery briefly, based on imaging results, FIGO stade and score are calculated to determine the risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started in case of high-risk disease.\n\nThe investigators have developped specific expertise at key levels of diagnosis, management, follow-up, fertility preservation and treatment.\n\nAssignments :\n\n* Registration and monitoring post diagnosis of complete or partial molar pregnancy, choriocarcinoma,PSTT, ETT, atypical placental site nodules\n* Histopathological analysis and genetics services\n* Measurement of human chorionic gonadotrophin (hCG) isoforms\n* Complex gynaecological surgery",[84,32,85,86],"Neoplasm, Trophoblastic","Hydatidiform Mole","Hydatidiform Mole, Invasive",[88,89,90,91,92,93,94,95],"Complete Hydatidiform mole","Partial Hydatidiform mole","Invasive mole","Choriocarcinoma","Post-molar neoplasia","Placental Site Trophoblastic Tumor (PSTT)","Epithelioid Trophoblastic Tumor (ETT)","hCG follow-up","2016-09-02",{"date":98,"type":21},"2016-09-08",{"date":100,"type":4},"1999-11",{"date":102,"type":21},"2029-11",{"name":104,"class":44},"Hospices Civils de Lyon"]