{ "data": { "asOf": "2026-10-30T22:26:47.238Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07828886", "title": "Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD", "scientificTitle": "Immunosenescence Phenotypes and Net Clinical Benefit of Advanced Therapies in Older Adults With Inflammatory Bowel Disease: A Prospective Multicenter Observational Cohort Study", "status": "not_yet_recruiting", "studyType": "observational", "phase": [], "conditions": [ "Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)", "Frailty", "Immunosenescence" ], "interventions": [], "sponsor": { "name": "First Affiliated Hospital, Sun Yat-Sen University", "type": "OTHER" }, "locations": [], "outcomes": { "other": [], "primary": [ "Net Clinical Benefit at Week 52" ], "secondary": [ "Steroid-Free Clinical Remission at Week 26", "Steroid-Free Clinical Remission at Week 52", "Advanced Therapy Persistence at Week 52", "Incidence of Serious Infection", "Incidence of IBD-Related Hospitalization", "Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 26", "Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 52", "Change From Baseline in Clinical Frailty Scale Score at Week 52" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\nAge 60 years or older. Confirmed diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified.\n\nPlanned initiation of a new advanced therapy, or initiation of the new advanced therapy within 4 weeks before enrollment.\n\nActive inflammatory bowel disease or another clinically documented indication for treatment escalation.\n\nAvailability of the core baseline clinical and laboratory data required for the study.\n\nExpected ability to complete at least 52 weeks of follow-up. Ability to provide written informed consent, or consent provided by a legally authorized representative when applicable.\n\nExclusion Criteria:\n\nUncertain diagnosis of inflammatory bowel disease or an alternative diagnosis that may mimic inflammatory bowel disease.\n\nActive severe infection at enrollment, including sepsis, active tuberculosis, uncontrolled viral hepatitis, cytomegalovirus disease, or another serious opportunistic infection.\n\nSignificant acute infection within 4 weeks before enrollment that, in the investigator's judgment, could substantially affect baseline immune-aging measurements or treatment safety assessment.\n\nActive malignancy or recent systemic anticancer treatment, except for adequately treated low-risk malignancies as permitted by the study protocol.\n\nSevere non-IBD-related immunodeficiency. End-stage disease or another condition associated with an expected life expectancy of less than 12 months.\n\nInability to obtain the core baseline variables required for the primary analyses.\n\nTreatment with the same index advanced therapy for more than 4 weeks before enrollment.\n\nParticipation in an interventional clinical trial that could interfere with the study assessments or outcomes.\n\nAny other condition that, in the investigator's judgment, would make participation inappropriate or prevent adequate follow-up.", "minimumAge": "60 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 300 }, "startDate": "2026-10-12", "completionDate": "2030-09-30", "lastUpdated": "2026-10-13T00:00:00.000Z", "firstPosted": "2026-09-18T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07828886" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07828886", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07828886", "sourceUrl": "https://clinicaltrials.gov/study/NCT07828886", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:56.418Z", "payloadSha256": "e8342c2f9a9da0e0ae3b6f2711f0980910870ce75185f50a0d78751d5a440bda", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07828886", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07828886", "verifyAt": "https://clinicaltrials.gov/study/NCT07828886", "retrievedAt": "2026-10-28T04:32:56.418Z", "payloadSha256": "e8342c2f9a9da0e0ae3b6f2711f0980910870ce75185f50a0d78751d5a440bda", "text": "ClinicalTrials.gov, record NCT07828886 (https://clinicaltrials.gov/study/NCT07828886), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07828886, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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