Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05554432
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2022-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the need for an additional EORTC quality of life module, or item list, to measure health-related quality of life in cancer patients who have received or are receiving immune checkpoint inhibitors.', 'timeFrame': 'At inclusion', 'description': 'Provisional item list(s) of quality of life issues important to people treated with immune checkpoint inhibitors.\n\nDevelopment of a strategy for the measurement of health-related quality of life in cancer patients who have received immune checkpoint inhibitors, alongside existing EORTC quality of life scales for cancer patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'IMMUNE CHECKPOINT INHIBITOR', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'Over the past 20 years, the views and experiences of patients in the field of oncology (through patient-reported outcomes, PROMs) have become increasingly important. When used in clinical trials, PROMs contribute to better detection and are used in clinical trials to improve the detection and management of treatment side effects. The Health-related quality of life assessments are widely used in oncology research, and the development of reliable and valid measurement instruments has become a major challenge.\n\nIn this context, health-related quality of life in cancer patients covers various aspects (functional status, physical or psychological symptoms) and several cancer-specific measurement instruments have been developed, including the EORTC QLQ-C30 quality of life questionnaire.\n\nAmong the different therapies used to treat cancers, immunotherapy with immune checkpoint inhibitors has been gaining momentum in recent years. Commonly used to treat a wide variety of cancers, it also has a wide range of known side effects.\n\nHowever, little is known about the health-related quality of life of patients patients who receive this therapy: specific self-questionnaires are almost non-existent or inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity. As for the data currently collected, they suffer from methodological problems.\n\nIn view of the increasing use of immune checkpoint inhibitors in cancer treatment, their known side effects and the lack of valid questionnaires specific to these treatments, it appears important to provide a valid questionnaire to take into account these impacts on the quality of life of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population is individuals aged over 18, with a diagnosis of cancer, who have received or are receiving treatment with one of the following:\n\n* anti-PD-1 (e.g., nivolumab, pembrolizumab, cemiplimab) or anti-PDL-1 (e.g., atezolizumab, avelumab, durvalumab) only\n* anti-PD-1 + anti-CTLA-4 (e.g., nivolumab + ipilumumab) only\n* anti-PD-1/anti-PDL-1 + chemotherapy\n\nExperienced HCPs who have worked with patients who have received or are receiving ICIs will be eligible for inclusion, in line with the EORTC QLG guidelines which state that HCPs should be interviewed for their views on HRQoL issues affecting these patients.', 'eligibilityCriteria': 'Patients :\n\nInclusion Criteria:\n\n* Provision of written informed consent to participate in the study\n* Has been diagnosed with cancer\n* Either currently receiving, or has received in the previous 12 months, one of the following:\n\n * an anti-PD-1 or anti-PDL-1 agent as the sole immune checkpoint inhibitor treatment (at least three cycles)\n * an anti-PD-1 or anti-PDL-1 agent in combination with an anti-CTLA-4 agent (at least one cycle)\n * cytotoxic chemotherapy and an anti-PD-1 or anti-PDL-1 agent (at least three cycles)\n* Aged ≥18 years\n\nExclusion Criteria:\n\n* Has an additional primary cancer for which they are receiving systemic therapy\n* Cognitive impairment which presents an obstacle to the completion of questionnaires or an interview\n* Poor command of the locally dominant language, or an inability to read questions\n* \\[Phase 1b only\\] Was interviewed for Phase 1a\n\nHealthcare professionals :\n\nInclusion Criteria:\n\n* Holds, or has held, a professional clinical position which involves working directly with cancer patients who are in receipt of immune checkpoint inhibitors\n* Is a medical oncologist, nurse specialist (or equivalent), psychologist, or social worker\n\nExclusion Criteria:\n\n• Has met the inclusion criteria for \\<1 years'}, 'identificationModule': {'nctId': 'NCT05554432', 'acronym': 'EORTC ICI', 'briefTitle': 'Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2', 'orgStudyIdInfo': {'id': 'IC 2022-03'}}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Brédart', 'role': 'CONTACT'}], 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Anne BREDART, PhD', 'role': 'CONTACT', 'email': 'anne.bredart@curie.fr', 'phone': '01 44 32 43 50', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}