Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-26 @ 11:31 PM
Study NCT ID:
NCT00899132
Status:
TERMINATED
Last Update Posted:
2015-09-29
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'C563236', 'term': 'Testicular Germ Cell Tumor'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'C562472', 'term': 'Teratoma, Testicular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}], 'ancestors': [{'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': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue samples from paraffin-embedded tissue blocks.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'whyStopped': 'Study due for continuing review', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of TAB3 transcript/protein as a molecular marker of cancer', 'timeFrame': 'end of study'}, {'measure': 'Characterization of TAB3 and its signaling networks that are involved in tumorigenesis', 'timeFrame': 'end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['skin cancer', 'small intestine cancer', 'pancreatic cancer', 'malignant testicular germ cell tumor', 'testicular teratoma'], 'conditions': ['Non-melanomatous Skin Cancer', 'Pancreatic Cancer', 'Small Intestine Cancer', 'Testicular Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor 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.\n\nPURPOSE: This research study is evaluating a tumor marker for testicular cancer, skin cancer, small intestine cancer, and pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To identify TAB3 transcript/protein as a molecular marker of cancer, specifically testicular, skin, small intestine, and pancreatic cancer.\n* To characterize TAB3 and its signaling networks that are involved in tumorigenesis.\n\nOUTLINE: Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care center', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Paraffin tissue blocks from surgical pathology cancer cases, specifically testicular, skin, small intestine, and pancreatic cancer, available\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00899132', 'briefTitle': 'Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'The Role of TAB3 Protein in Tumorigenesis', 'orgStudyIdInfo': {'id': 'CASE5Y06'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE5Y06', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'CASE-5Y06-CC191', 'type': 'OTHER', 'domain': 'Cancer Center IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'in situ hybridization', 'type': 'GENETIC', 'description': 'Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.'}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.'}, {'name': 'immunologic technique', 'type': 'OTHER', 'description': 'Tumor tissue samples from paraffin-embedded tissue blocks are analyzed for TAB3 transcript and protein expression using in situ hybridization and immunostaining with TAB3 cRNA probe and antibody. Antibodies against the proteins involved in the NFkB signaling pathway (e.g., p65, TAK1, MyD88, and Akt) are used in the immunostaining assays.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ge Jin, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}