Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-03-20 @ 11:09 PM
Study NCT ID:
NCT05331066
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2022-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding immunE-related toXicities by multifACeT Profiling
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-04-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact on patients quality of life using patient questionnaires', 'timeFrame': '60 months', 'description': '• Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs.'}], 'primaryOutcomes': [{'measure': 'Patients who experience irAEs', 'timeFrame': '36 months', 'description': 'To determine the proportion of patients who experience irAEs during treatment with CPI.'}], 'secondaryOutcomes': [{'measure': 'Biological and clinical characteristics', 'timeFrame': '60 months', 'description': 'To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs).'}, {'measure': 'Time to development of irAEs', 'timeFrame': '36 months', 'description': 'To determine time to clinical development of irAEs during treatment with CPI.'}, {'measure': 'Proportion of patients experiencing irAEs', 'timeFrame': '60 months', 'description': '• To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': 'A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.', 'detailedDescription': 'The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.\n\nFurther assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.\n\nIrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age 18 years or older\n* Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy\n\nExclusion Criteria:\n\n* Medical or psychological condition that would preclude informed consent\n* Planned participation in a drug trial receiving investigational agents\n* Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.\n* Subjects unable to comply with the study or sample schedule.'}, 'identificationModule': {'nctId': 'NCT05331066', 'acronym': 'EXACT', 'briefTitle': 'Understanding immunE-related toXicities by multifACeT Profiling', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'EXACT - Understanding immunE-related toXicities by multifACeT Profiling', 'orgStudyIdInfo': {'id': '5064'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'Chelsea', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dilruba Kabir', 'role': 'CONTACT', 'email': 'dilruba.kabir@rmh.nhs.uk', 'phone': '02073528171'}], 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.48755, 'lon': -0.16936}}], 'centralContacts': [{'name': 'Laura Boddy', 'role': 'CONTACT', 'email': 'exact@rmh.nhs.uk', 'phone': '020 7352 8171'}, {'name': 'Arjun Modi', 'role': 'CONTACT', 'email': 'exact@rmh.nhs.uk'}], 'overallOfficials': [{'name': 'Samra Turajlic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}