Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 11:28 PM
Study NCT ID:
NCT07035067
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-23
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidimensional Burden of Platinum Resistant Ovarian Cancer (PROC) on Patients and Caregivers in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], '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'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the quality of life of patient with ovarian cancer', 'timeFrame': 'At recruitment', 'description': 'Using the the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) and EuroQol 5-dimendion 5-level (EQ-5D-5L)'}], 'secondaryOutcomes': [{'measure': "Patient's symptoms assessment", 'timeFrame': 'At recruitment', 'description': 'Using the Measure of Ovarian Symptoms and Treatment (MOST-T24 (V2))'}, {'measure': "Caregiver's Quality of Life", 'timeFrame': 'At recruitment', 'description': 'Using the CareGiver Oncology Quality of Life (CarGOQoL) questionnaire'}, {'measure': 'Patients and caregivers work productivity loss and activity impairment', 'timeFrame': 'At recruitment', 'description': 'Using the Work Productivity and Activity Impairment (WPAI) questionnaire'}, {'measure': "Patient's preference in treatment", 'timeFrame': 'At recruitment', 'description': 'Using a questionnaire specifically developed for this study based on a literature search, physician input and patient association input.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'Caregiver Burden', 'Patient Burden']}, 'descriptionModule': {'briefSummary': 'Filling the gap in Canadian evidence on the burden of PROC on QoL is essential. It will help better understand the impact of PROC on multiple aspects of the lives of patients and their caregivers and the real-life hurdles faced by PROC patients and their caregivers. The outputs of this study will help better understand the hurdles and challenges they face and the significant unmet medical need.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ovarian cancer and caregivers of patients with ovarian cancer who are part Ovarian Cancer Canada mailing list.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patient Inclusion Criteria\n\n1. ≥18 years old\n2. Patients with PROC who received \\>1 prior line of therapy identified through a screening survey. PROC will be defined as recurrence less than 6 months after last platinum chemotherapy (i.e. carboplatin or cisplatin)\n3. Ability to read and understand French or English\n4. Signature of ICF\n\nPatients Exclusion Criteria\n\n1. Patients with PSOC, defined as those who:\n\n 1. Have not progressed within less than 6 months after completion of platinum-based chemotherapy or;\n 2. Are still on platinum chemotherapy or;\n 3. Receive maintenance therapy.\n2. Patients with platinum-refractory ovarian cancer, defined as not responding or disease progressing during therapy or within three months after the last dose\n\nCaregivers Inclusion Criteria:\n\n1. ≥18 years old\n2. Current caregiver of a patient with PROC (see definition to be used above) who received \\>1 prior line of therapy identified through a screening survey.\n3. Ability to read and understand French or English\n4. Signature of ICF.\n\nCaregivers Exclusion Criteria:\n\n1. Caregivers of patients with PSOC (see definition above)\n2. Caregivers of PROC patients who have passed away\n3. Caregivers of platinum-refractory patients (see definition above)'}, 'identificationModule': {'nctId': 'NCT07035067', 'briefTitle': 'Multidimensional Burden of Platinum Resistant Ovarian Cancer (PROC) on Patients and Caregivers in Canada', 'organization': {'class': 'OTHER', 'fullName': 'PeriPharm'}, 'officialTitle': 'Multidimensional Burden of Platinum Resistant Ovarian Cancer (PROC) on Patients and Caregivers in Canada', 'orgStudyIdInfo': {'id': 'Ovarian Cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with PROC part of Ovarian Cancer Canada mailing lists', 'interventionNames': ['Other: No intervention']}, {'label': 'Caregiver of PROC patients part of Ovarian Cancer Canada mailing lists', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No specific intervention is assess in this study.', 'armGroupLabels': ['Caregiver of PROC patients part of Ovarian Cancer Canada mailing lists', 'Patients with PROC part of Ovarian Cancer Canada mailing lists']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2Y 1V3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'PROxy Network, an initiative of PeriPharm Inc.', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PeriPharm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}