Viewing Study NCT00965861


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Study NCT ID: NCT00965861
Status: TERMINATED
Last Update Posted: 2013-08-28
First Post: 2009-08-24
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: SCRI Tissue Testing Registry
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Potential retention of tissue blocks for future study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Replaced by a study with a similar design.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish an electronic registry to store information from patients who have provided their consent allowing use of their tissue sample(s) for future testing.', 'timeFrame': '120 months'}, {'measure': 'To perform testing on the tissue samples to learn more about specific types of cancer and/or other diseases', 'timeFrame': '120 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tissue Registry', 'Tissue Collection', 'Unknown Primary', 'Breast', 'Lung', 'Gastrointestinal', 'Bone Marrow Transplant', 'Chronic Lymphocytic Leukemia', 'Central Nervous System', 'Head and Neck', 'Melanoma', 'Myelodysplastic syndrome', 'Multiple Myeloma', 'Lymphoma', 'Gynecologic', 'Genitourinary', 'Refractory Malignancy'], 'conditions': ['Melanoma', 'Myelodysplastic Syndrome', 'Multiple Myeloma', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.', 'detailedDescription': 'Sarah Cannon Research Institute (SCRI) is committed to improvement and excellence in clinical research and correlative science. To this end, the SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date. Future testing may include assays for newly identified markers of potential prognostic and/or therapeutic value. These markers may be specific to an individual cancer type, or they may be present more generally in cancer and/or other conditions.\n\nThis study will consist of a registry of patients who have agreed to allow their tissue sample(s) (even those taken prior to their participation in an SCRI-sponsored trial) to be used by the SCRI Oncology Research Consortium at some point in the future for testing and analysis of expression analysis and/or analysis of tumor markers. The registry will be contained in an electronic database, and will be sorted by disease indication. (Note: Patients will not be asked to return at a future date and have tissue samples collected; rather, SCRI will have the authorization to obtain pre-existing samples).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be \\>= 18 years of age.\n* Patients must be able to provide written informed consent.\n\nExclusion Criteria:\n\n* Not Applicable'}, 'identificationModule': {'nctId': 'NCT00965861', 'briefTitle': 'SCRI Tissue Testing Registry', 'organization': {'class': 'OTHER', 'fullName': 'SCRI Development Innovations, LLC'}, 'officialTitle': 'SCRI Tissue Testing Registry', 'orgStudyIdInfo': {'id': 'SCRI MISC 39'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The SCRI Oncology Research Consortium will collect written consent from patients allowing the use of their tumor tissue sample(s) for testing/analysis at a future date.', 'interventionNames': ['Other: Tissue Registry Study']}], 'interventions': [{'name': 'Tissue Registry Study', 'type': 'OTHER', 'description': 'If a patient consents to allowing the use of their tumor tissue sample(s) for testing/analysis at a future date, their name and information will be stored electronically in a registry that will be managed by SCRI. SCRI may then use the information contained in this registry (such as disease indication, demographic information, etc.) at any time in the future to select tissue samples on which to perform testing/analyses.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37023', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Howard Burris, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'SCRI Development Innovations, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}