Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-06 @ 6:06 PM
Study NCT ID:
NCT02810405
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Tissue Blocks or Slides From Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain tissue blocks and slides in order to store them for future studies and analysis (e.g., using molecular technology platforms).', 'timeFrame': 'duration of protocol', 'description': 'To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB)Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sample', 'Storage', 'Molecular Profiling', 'Biopsy', 'Repository', 'Natural History'], 'conditions': ['Tumor', 'Carcinogens', 'Neoplasm, Benign', 'Benign Neoplasms', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '18314063', 'type': 'BACKGROUND', 'citation': 'Voduc D, Kenney C, Nielsen TO. Tissue microarrays in clinical oncology. Semin Radiat Oncol. 2008 Apr;18(2):89-97. doi: 10.1016/j.semradonc.2007.10.006.'}, {'pmid': '14654795', 'type': 'BACKGROUND', 'citation': 'Sauter G, Simon R, Hillan K. Tissue microarrays in drug discovery. Nat Rev Drug Discov. 2003 Dec;2(12):962-72. doi: 10.1038/nrd1254. No abstract available.'}, {'pmid': '19389554', 'type': 'BACKGROUND', 'citation': 'Blonder J, Veenstra TD. Clinical proteomic applications of formalin-fixed paraffin-embedded tissues. Clin Lab Med. 2009 Mar;29(1):101-13. doi: 10.1016/j.cll.2009.01.006.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2011-C-0190.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'BACKGROUND:\n\nCancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level. Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine. The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies. The ultimate goal is to understand the molecular indicators of cancer development and progression. While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies. There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks. The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research. This protocol will describe the procedures for receiving, labeling and storing paraffin-embedded tissue blocks and/or slides until they are needed for future analysis. When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.\n\nOBJECTIVE:\n\n\\- To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Medical Oncology Branch (MOB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).\n\nELIGIBILITY:\n\n\\- Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Medical Oncology Branch and Affiliates Clinics, NCI.\n\nDESIGN:\n\n* Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the MOB/CCR/NCI for coding.\n* Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.', 'detailedDescription': 'Background\n\n* Cancer of any type is a serious disease and despite all the progress made from past research, there is still much that is poorly understood at the molecular level.\n* Recent advances in biomedical technology platforms have emerged as critical tools for accelerating personalized medicine.\n* The collection of human tissue specimens has been an invaluable resource for conducting translational cancer research using these developing technologies.\n* The ultimate goal is to understand the molecular indicators of cancer development and progression.\n* While it is ideal to be able to study clinical samples, specifically tissue biopsies, they are however precious and are often difficult to obtain in sufficient quantities or numbers to conduct proteomic or molecular profiling studies.\n* There exists, however, a vast archive of pathologically characterized clinical samples in the form of formalin-fixed paraffin-embedded tissue blocks.\n* The preservation of these tissue blocks and/or slides for long-term (years) storage is an important asset that aids in translational and clinical research.\n* This protocol will describe the procedures for receiving, labeling and storing paraffinembedded tissue blocks and/or slides until they are needed for future analysis.\n* When blocks are ready for analysis, the requestor will then follow the IRB protocol specific to that study.\n\nObjective\n\n-To obtain tissue blocks and slides from outside pathology departments for cancer patients being treated at the Genitourinary Malignancies Branch (GMB) and Affiliates Center for Cancer Research (CCR), National Cancer Institute (NCI) in order to store them for future studies and analysis (e.g., using molecular technology platforms).\n\nEligibility\n\n-Patients suspected of having, or with biopsy proof of malignant disease will be evaluated in the Genitourinary Malignancies Branch (GMB) and Affiliates Clinics, NCI.\n\nDesign\n\n* This protocol is not a research study.\n* Tissue blocks and slides will be acquired from outside pathology departments and received by the Clinical Pharmacology Program of the OCD/CCR/NCI for coding.\n* Bar-coded tissue blocks and slides will then be transferred to the Laboratory of Pathology/CCR/NCI for proper long-term storage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any cancer patient who is being evaluated at the NCI with available tissue samples', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Any cancer patient who is being evaluated at the National Cancer Institute with available tissue samples (blocks or slides) is eligible\n* Must be able and willing to sign an informed consent for this study\n* Age: greater than or equal to 18 years of age\n\nEXCLUSION CRITERIA:\n\n-None'}, 'identificationModule': {'nctId': 'NCT02810405', 'briefTitle': 'Collection of Tissue Blocks or Slides From Patients With Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Collection of Tissue Blocks or Slides From Patients With Cancer', 'orgStudyIdInfo': {'id': '110190'}, 'secondaryIdInfos': [{'id': '11-C-0190'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1/Patient Samples', 'description': 'Patients treated at NCI with available tissue samples.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'William D Figg, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Clinical data available during the study and indefinitely.', 'ipdSharing': 'YES', 'description': 'All IPD recorded in the medical record will be shared with intramural investigators upon request.', 'accessCriteria': 'Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}