Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT00355758
Status:
TERMINATED
Last Update Posted:
2010-09-01
First Post:
2006-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling
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_WITHOUT_DNA', 'description': 'Whole blood is collected from subjects. The whole blood is spun down by centrifugation and only serum is retained and stored.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Lack of personnel', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-31', 'studyFirstSubmitDate': '2006-07-24', 'studyFirstSubmitQcDate': '2006-07-24', 'lastUpdatePostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer Detection by Serum Proteomic Profiling'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': ': Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.', 'detailedDescription': 'A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For all subjects:\n\n * Men 50 years of age or older.\n * Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.\n * It has been determined by the treating physician that a prostate biopsy is clinically indicated.\n * Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.\n\nFor study on treatment effect\n\n* Men with clinically localized prostate cancer (total PSA \\< 20 ng/ml and clinical T2b or less).\n* Men with organ confined prostate cancer as determined by final pathologic diagnosis.\n\nExclusion Criteria:\n\n* Exclusion criteria for all subjects:\n\n * Known prostate cancer or prior treatment for prostate cancer.\n * Acute prostatitis.\n * Untreated urinary tract infection.\n * Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.\n * Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.\n\nExclusion Criteria (for study on treatment effect)\n\n* Men with non-organ confined prostate cancer.\n* Men with detectable serum PSA levels more than 1 months following radical prostatectomy."}, 'identificationModule': {'nctId': 'NCT00355758', 'briefTitle': 'UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Prostate Cancer Detection by Serum Proteomic Profiling', 'orgStudyIdInfo': {'id': '2004-3561'}}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Atreaya Dash, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Atreya Dash, MD', 'oldOrganization': 'University of California, Irvine'}}}}