Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-13 @ 12:24 AM
Study NCT ID:
NCT01544569
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2012-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017404', 'term': 'In Situ Hybridization, Fluorescence'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D002874', 'term': 'Chromosome Mapping'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'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': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2012-02-29', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression and function of transposons in rhabdoid tumors'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rhabdoid tumor of the kidney'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.\n\nPURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* To investigate the expression and function of transposons in 50 primary rhabdoid tumors.\n\nOUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'rhabdoid tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Freshly frozen rhabdoid tumors from either renal or extra-renal sites from children younger than 2 years of age\n* Clinical patient information (age, gender, comorbidities, tumor stage, size, pathology, therapy, outcome) available\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT01544569', 'briefTitle': 'Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Endogenous DNA Transposition in Rhabdoid Tumors', 'orgStudyIdInfo': {'id': 'AREN12B3'}, 'secondaryIdInfos': [{'id': 'COG-AREN12B3', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000727229', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'AREN12B3', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2012-00689', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC'}, {'name': 'fluorescence in situ hybridization', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'gene mapping', 'type': 'GENETIC'}, {'name': 'microarray analysis', 'type': 'GENETIC'}, {'name': 'polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'protein expression analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'medical chart review', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elizabeth A. Mullen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}