Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-23 @ 4:10 AM
Study NCT ID:
NCT06751303
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient decision for use of PARPi therapy', 'timeFrame': '6 Monhs', 'description': 'The proportion of HRP patients who choose to undergo PARP therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PARPi', 'HRD testing'], 'conditions': ['Ovarian Cancer', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.\n\nWe hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol\n\nExclusion Criteria:\n\n* Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing'}, 'identificationModule': {'nctId': 'NCT06751303', 'acronym': '4PDQ', 'briefTitle': "Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's", 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Patient Preferences for Precision Medicine', 'orgStudyIdInfo': {'id': '4118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HRD Tested', 'description': 'HRP patients are given a decision aid, while HRD patients are not given a decision.', 'interventionNames': ['Other: Patients that are HRP are given a decision aid for PARPi use']}], 'interventions': [{'name': 'Patients that are HRP are given a decision aid for PARPi use', 'type': 'OTHER', 'description': 'Study created patient decision aid if the first for HRD tested Ovarian Cancer patients', 'armGroupLabels': ['HRD Tested']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7V4H4', 'city': 'Saskatoon', 'state': 'S', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Susan Kaban', 'role': 'CONTACT', 'email': 'susan.kaban@saskcancer.ca', 'phone': '306-655-2691'}], 'facility': 'Saskatchewan Cancer Center', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Oncology', 'investigatorFullName': 'Laura Hopkins', 'investigatorAffiliation': 'University of Saskatchewan'}}}}