Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-15 @ 11:18 AM
Study NCT ID:
NCT01642095
Status:
WITHDRAWN
Last Update Posted:
2018-08-07
First Post:
2012-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Biomarkers in Samples From Younger Patients With Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D018201', 'term': 'Nephroma, Mesoblastic'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2012-07-15', 'studyFirstSubmitQcDate': '2012-07-15', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FAK expression in pediatric renal tumors', 'timeFrame': 'Baseline'}]}, 'conditionsModule': {'conditions': ['Childhood Kidney Neoplasm', 'Clear Cell Renal Cell Carcinoma', 'Congenital Mesoblastic Nephroma', 'Rhabdoid Tumor of the Kidney']}, 'descriptionModule': {'briefSummary': 'This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.\n\nOUTLINE:\n\nArchived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:\n\n * Anaplastic Wilms tumor\n * Malignant rhabdoid tumor of the kidney\n * Clear cell sarcoma of the kidney\n * Mesoblastic nephroma'}, 'identificationModule': {'nctId': 'NCT01642095', 'briefTitle': 'Studying Biomarkers in Samples From Younger Patients With Kidney Cancer', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Focal Adhesion Kinase Expression in Pediatric Renal Tumors', 'orgStudyIdInfo': {'id': 'AREN12B8'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01987', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000736805'}, {'id': 'AREN12B8'}, {'id': 'COG-AREN12B8'}, {'id': 'AREN12B8', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'AREN12B8', 'type': 'OTHER', 'domain': 'CTEP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basic science (FAK expression)', 'description': 'Archived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.', 'interventionNames': ['Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Basic science (FAK expression)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Childrens Oncology Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Elizabeth Beierle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}