Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00767533
Status:
TERMINATED
Last Update Posted:
2016-07-22
First Post:
2008-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunobiology of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'PI left', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.', 'detailedDescription': 'BACKGROUND\n\nWe have previously demonstrated that tumor-specific T cells could be identified in \\>50% of patients with metastatic melanoma and these cells appeared to be rendered anergic in vivo \\[Nature Medicine 5:677, 1999\\]. Recently we discovered that there is a signaling defect in the Interferon (IFN) pathway in immune cells from melanoma patients \\[PLOS Medicine 4:897 2007\\]. Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished). We would like to expand our research to all types of cancer to determine whether these phenomena occur in different cancer types.\n\nOBJECTIVES\n\nOur primary objective is to determine whether there is an IFN signaling defect in different types of cancers and to determine what is causing this defect.\n\nThe second objective is to determine whether these PBMCs are rendered anergic.\n\nINVESTIGATIONAL PLAN\n\nThe study population will consist of patients who have been diagnosed with cancer, regardless of sex or ethnicity. Blood will be collected during the subjects regularly scheduled laboratory appointment and peripheral blood mononuclear cells (PBMCs) will be isolated for research purposes. These PBMCs will undergo studies, i.e. phosflow, qPCR, proliferation, survival, etc., to determine immune responses for T cells (CD4 and CD8), B cells (CD19), natural killer cells (CD16), and possibly monocytes (CD14).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over. Exclusion Criteria:Participants who have an autoimmune disorder and/or are under the age of 18 years.'}, 'identificationModule': {'nctId': 'NCT00767533', 'briefTitle': 'Immunobiology of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Immunobiology of Cancer', 'orgStudyIdInfo': {'id': 'VAR0033'}, 'secondaryIdInfos': [{'id': 'SU-10012008-1313', 'type': 'OTHER', 'domain': 'Stanford University alternate IRB Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Peter P Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}