Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT01572467
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2012-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007984', 'term': 'Leydig Cell Tumor'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'C562841', 'term': 'Ovarian Germ Cell Cancer'}], 'ancestors': [{'id': 'D018310', 'term': 'Sertoli-Leydig Cell Tumor'}, {'id': 'D018312', 'term': 'Sex Cord-Gonadal Stromal Tumors'}, {'id': 'D018309', 'term': 'Neoplasms, Gonadal Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leydig cell tumor', 'ovarian stromal cancer', 'childhood malignant testicular germ cell tumor', 'childhood malignant ovarian germ cell tumor'], 'conditions': ['Childhood Germ Cell Tumor', 'Leydig Cell Tumor', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.\n\nPURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.\n\nOUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Ovarian or Testicular Sex Cord Stromal Tumors', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Fixed and frozen tissue samples from the ATBR01 B1 tissue bank and from the International Pleuropulmonary Blastoma Registry, Children's Hospital of Boston, and Massachusetts General Hospital\n* Tissue samples from patients diagnosed with:\n\n * Ovarian\n\n * Sertoli-Leydig cell tumor\n * Juvenile granulosa cell tumor\n * Adult granulosa cell tumor\n * Gynandroblastoma\n * Sex cord stromal tumor with annular tubules\n * Sex cord stromal tumor, undifferentiated\n * Sertoli tumor\n * Leydig tumor\n * Testicular:\n\n * Granulosa cell tumor\n * Sertoli tumor\n * Leydig tumor\n * Sertoli-Leydig\n * Undifferentiated stromal tumor\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT01572467', 'briefTitle': 'Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood', 'orgStudyIdInfo': {'id': 'ARAR12B2'}, 'secondaryIdInfos': [{'id': 'COG-ARAR12B2', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2012-00721', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ARAR12B2', 'type': 'OTHER', 'domain': "Children's Oncology Group"}]}, 'armsInterventionsModule': {'interventions': [{'name': 'RNA analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'mutation analysis', 'type': 'GENETIC'}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'medical chart review', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dana A. Hill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}