Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-26 @ 2:04 PM
Study NCT ID:
NCT00584792
Status:
COMPLETED
Last Update Posted:
2008-01-02
First Post:
2007-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet, Genetic Variation and Prostate Cancer Among African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum collected for Ancestry Imformative Markers (AIMS) testing along with PSA and CRP.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-22', 'studyFirstSubmitDate': '2007-12-22', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is there a difference in ancestry percentage between the controls (no cancer) and the cases (prostate cancer)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "This is a single center pilot study to asses the feasibility of conducting a larger population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer Center's Development Award Program. The hypothesis is that the percent african ancestry in an individual may determine their prognosis if diagnosed with prostate cancer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African American males between the ages of 35 and 75.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSelf-identification as a male with African ancestry Between ages of 35-75\n\nExclusion Criteria:\n\nNo African ancestry Not between ages of 35-75\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00584792', 'briefTitle': 'Diet, Genetic Variation and Prostate Cancer Among African Americans', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Diet, Genetic Variation and Prostate Cancer Among African Americans', 'orgStudyIdInfo': {'id': '200614379'}, 'secondaryIdInfos': [{'id': 'AA Pilot Study'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Controls (No prostate cancer)'}, {'label': '2', 'description': 'Cases (Prostate Cancer Diagnosed)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lesley Butler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lesley Butler, PhD', 'oldOrganization': 'University of California, Davis'}}}}