Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00373035
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013058', 'term': 'Mass Spectrometry'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unique proteins or peptides associated with prostate cancer'}]}, 'conditionsModule': {'keywords': ['prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy).\n\nSecondary\n\n* Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine.\n\nOUTLINE: This is a pilot study.\n\nPatients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer\n\nPATIENT CHARACTERISTICS:\n\n* No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin\n* No serious medical or psychiatric illness that would preclude informed consent\n* No concurrent acute illness\n\nPRIOR CONCURRENT THERAPY:\n\n* No participation in another clinical trial within the past 30 days\n* No more than one enrollment into this study'}, 'identificationModule': {'nctId': 'NCT00373035', 'briefTitle': 'Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Biomarkers of Prostate Cancer', 'orgStudyIdInfo': {'id': 'CCCWFU-85A03'}, 'secondaryIdInfos': [{'id': 'CDR0000490117', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'CCCWFU-BG03-628'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'proteomic profiling', 'type': 'GENETIC'}, {'name': 'immunological diagnostic method', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'mass spectrometry', 'type': 'OTHER'}, {'name': 'biopsy', 'type': 'PROCEDURE'}, {'name': 'ultrasound imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'SurroMed Incorporated', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Frank M. Torti, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}