Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 4:38 AM
Study NCT ID:
NCT03485794
Status:
TERMINATED
Last Update Posted:
2025-08-12
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection of Blood in Studying Metabolites in Patients With Prostate Cancer
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': 'Plasma, PBMCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Insufficient Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood sample collection', 'timeFrame': 'Baseline', 'description': 'The blood will be used to analyze the metabolites produced by white blood cells.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting.\n\nII. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.\n\nIII. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells \\[RBCs\\], and whole blood).\n\nIV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state.\n\nOUTLINE:\n\nPatients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with prostate cancer who are patients at the University of Southern California (USC) Westside Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects will have histologically confirmed prostate cancer\n* Provide written consent/authorization to participate in this study\n* Have no signs or symptoms of active infection\n* Exhibit a willingness to comply with the experimental procedures as outlined in this protocol'}, 'identificationModule': {'nctId': 'NCT03485794', 'briefTitle': 'Collection of Blood in Studying Metabolites in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': '4P-17-8'}, 'secondaryIdInfos': [{'id': 'NCI-2017-02078', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '4P-17-8', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic (biospecimen collection)', 'description': 'Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of blood', 'armGroupLabels': ['Diagnostic (biospecimen collection)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (biospecimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jonathan Katz, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}