Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-04 @ 4:58 AM
Study NCT ID:
NCT01954004
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1270}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "• The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.", 'timeFrame': '4 months'}], 'primaryOutcomes': [{'measure': 'Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation)', 'timeFrame': '1 month'}, {'measure': 'Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recently diagnosed treatment-naïve patients with early stage localized prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.\n* Clinically localized (no evidence on clinical or imaging studies of advanced disease).\n* No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.\n* Sufficient amount of tissue remains from biopsy to perform genomic testing.\n\nExclusion Criteria:\n\n* Patients with a known history of hypogonadism'}, 'identificationModule': {'nctId': 'NCT01954004', 'briefTitle': 'Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myriad Genetic Laboratories, Inc.'}, 'officialTitle': 'An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'PROCEDE-1000'}}, 'contactsLocationsModule': {'locations': [{'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Richard Wenstrup, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Myriad Genetic Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myriad Genetic Laboratories, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}