Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-06 @ 9:19 PM
Study NCT ID:
NCT01514669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive 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': 'Tear Sample collection; serum sample collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Sample', 'timeFrame': '1 day', 'description': 'Tear sample will be taken at the initial clinic visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from those outpatients followed in the Winthrop P. Rockefeller Cancer Institute (located at the University of Arkansas for Medical Sciences).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male, 35-85 years old\n2. Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.)\n3. Patients who present for the evaluation of a palpable nodule or induration on prostate exam\n4. Patients who meet the requirements of Group 1, 2, or 3 of the protocol\n\nExclusion Criteria:\n\n1. Patient \\< 35 or \\> 85 years of age\n2. Concurrent eye infection or trauma, including active conjunctivitis\n3. Abnormal production of tears (too much or too little)\n4. Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment\n5. Atypia on prostate biopsy report'}, 'identificationModule': {'nctId': 'NCT01514669', 'briefTitle': 'Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer', 'orgStudyIdInfo': {'id': '133719'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No treatment', 'description': 'No Tx, this is observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Alan Diekman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}