Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-20 @ 8:38 AM
Study NCT ID:
NCT02454595
Status:
TERMINATED
Last Update Posted:
2017-09-05
First Post:
2015-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry to Measure the Impact of Adding Genomic Testing
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': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Formalin-fixed paraffin-embedded (FFPE) tissue from blocks or slides of prostatic adenocarcinoma biopsies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2015-05-04', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of genomic test results towards selecting a first-line therapy option for newly diagnosed, localized, prostate cancer patients.', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.', 'detailedDescription': 'This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed ( ≤ 6 months), untreated patients with histologically proven adenocarcinoma of the prostate', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed (\\< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:\n* PSA less than or equal to 10 ng/dl and\n* Gleason's 7 (4+3 or 3+4) or Gleason's 6 and\n* Age greater than 55 years old and\n* Clinical Stage T1 or T2\n* Clinically localized (no evidence on clinical or imaging studies of advanced disease).\n* No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.\n\nExclusion Criteria:\n\n\\- Known history of hypogonadism"}, 'identificationModule': {'nctId': 'NCT02454595', 'briefTitle': 'Registry to Measure the Impact of Adding Genomic Testing', '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 at Intermountain Hospitals', 'orgStudyIdInfo': {'id': 'URO-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Registry', 'type': 'BEHAVIORAL', 'otherNames': ['Prolaris'], 'description': 'Physician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Healthcare', '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'}, 'collaborators': [{'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}