[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-germ-cell-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-germ-cell-tumor":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100482591","molecular-epidemiology-of-pediatric-germ-cell-tumors-100482591",false,"NCT05564026","Molecular Epidemiology of Pediatric Germ Cell Tumors","Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics","Inclusion Criteria:\n\n* Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.\n* The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.\n* Patients must be diagnosed at \\\u003C 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.\n* Participants must be able to complete study related documents in English or Spanish.\n* All patients and\u002For their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.\n* All institutional, FDA, and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish","ALL",{"count":18,"type":19},1151,"ESTIMATED","OBSERVATIONAL","A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.",[23,24,25,26,27,28,29,30,31],"Germ Cell Tumor","Germinoma","Teratoma","Embryonal Carcinoma","Yolk Sac Tumor","Choriocarcinoma","Mixed Germ Cell Tumor","Late Effects","Pediatric Germ Cell Tumor","RECRUITING","2025-10-23",{"date":35,"type":36},"2025-10-24","ACTUAL",{"date":38,"type":36},"2023-04-12",{"date":40,"type":19},"2027-06-30",{"name":42,"class":43},"Children's Oncology Group","NETWORK",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100474285","phase-2-paclitaxelifosfamidecisplatin-chemotherapy-for-high-risk-pediatric-germ-cell-tumor-100474285","NCT05455918","Paclitaxel\u002FIfosfamide\u002FCisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor","Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel\u002FIfosfamide\u002FCisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor","Inclusion Criteria:\n\n* Over 1 year old and less than 20 years old\n* Pathologically or cytologically diagnosed germ cell tumor\n* Germ cell tumor which has not been treated previously\n* Higher than stage II (stage I should be excluded)\n* Pathologic type\n\n  1. embryonal carcinoma\n  2. choriocarcinoma\n  3. yolk sac tumor\n  4. teratoma with malignant germ cell tumor elements\n* High risk definition\n\n  1. More than 11 years old, male or female\n  2. Less than 11 years old, male or female\n\n     1. Extragonodal germ cell tumor, stage III\n     2. Extragonodal germ cell tumor, stage IV\n     3. Ovarian germ cell tumor, stage IV\n* More than 8 weeks of life expectancy\n* performance level : ECOG Performance score 0, 1, or 2\n* informed consent should be obtained\n\nExclusion Criteria:\n\n* pregnancy or lactating patients (fertile men or women should agree to avoid pregnancy during the trial period)\n* previously reported allergy or hypersensitivity to trial chemotherapeutic agent\n* severe hypersensitivity to the agent containing Cremophor R EL (polyoxyethylated castor oil)\n* Acceptable organ functions\n\n  1. Bone marrow : Absolute neutrophil count \\>=1000\u002FµL , platelet \\>= 100000\u002FµL\n  2. Renal function : serum creatinine ≤ 1.5 x upper limit of normal (ULN)\n  3. Hepatic function : total bilirubin ≤ 1.5 x ULN, ALT ≤ 3.0 x UNL\n  4. Cardiac Function : Ejection fraction ≥ 50%\n  5. Uncontrolled infection\n  6. Uncontrolled urinary obstruction\n  7. Uncontrolled cystitis\n* Followings will be excluded\n\n  1. Mature teratoma\n  2. Gliomatosis Peritonei\n  3. Low Risk Germ Cell Tumor\n  4. testicular stage I\n  5. ovarian stage I\n  6. recurrent, refractory tumor\n* Concomitant other trial agent beside the agents in this trial\n* Concomitant chemotherapeutic agents besides the agents in this trial\n\n  1. Concomitant tumor other than germ cell tumor\n  2. Other trial agents\n  3. Other chemotherapeutic agents","MALE","1 Year","20 Years",{"count":56,"type":19},42,"INTERVENTIONAL",[59],"PHASE2","Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.\n\nPaclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.",[31],"2022-07-08",{"date":64,"type":36},"2022-07-13",{"date":66,"type":36},"2020-07-26",{"date":68,"type":19},"2028-06",{"name":70,"class":71},"Yonsei University","OTHER"]