{"type":"trials","record":{"id":9659,"source_id":"clinicaltrials-gov","external_id":"NCT07828886","title":"Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD","brief_summary":"The goal of this observational study is to learn whether signs of immune aging and frailty can help predict the balance of benefits and risks of advanced therapies in adults aged 60 years or older with inflammatory bowel disease (IBD) who are starting a new advanced therapy. Treatment will be chosen by the participant's usual clinical team and will not be assigned by the study. The main questions it aims to answer are: Are baseline immune-aging and frailty characteristics associated with net clinical benefit at 52 weeks, defined as steroid-free clinical remission without serious infection, treatment discontinuation because of adverse events, IBD-related hospitalization, or IBD-related surgery? Can a low-cost combination of clinical and laboratory markers help identify older adults with IBD who are more likely to have favorable or unfavorable outcomes after starting advanced therapy? Participants will: Continue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors. Have routine and study-related blood tests, including measures related to immune aging such as CD4/CD8 ratio and interleukin-6 (IL-6). Be followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible. Have information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"First Affiliated Hospital, Sun Yat-Sen University","enrollment":300,"countries":[],"start_date":"2026-09-01","completion_date":"2030-09-30","last_update_date":"2026-09-22","source_url":"https://clinicaltrials.gov/study/NCT07828886","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-18T12:17:31.680197+00:00","last_seen_at":"2026-09-25T06:15:06.064+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years","comparator":null,"organization":"First Affiliated Hospital, Sun Yat-Sen University","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Net Clinical Benefit at Week 52 — 52 Weeks","Steroid-Free Clinical Remission at Week 26 — 26 Weeks","Steroid-Free Clinical Remission at Week 52 — 52 weeks","Advanced Therapy Persistence at Week 52 — 52 weeks","Incidence of Serious Infection — From Baseline Through Week 52","Incidence of IBD-Related Hospitalization — From Baseline Through Week 52","Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 26 — Baseline and Week 26","Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 52 — Baseline and Week 52","Change From Baseline in Clinical Frailty Scale Score at Week 52 — Baseline and Week 52"],"design_description":null,"source_has_results":false},"controlled_terms":["Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Frailty","Immunosenescence"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: immune aging.","quality_checked_at":"2026-09-25T06:15:09.632521+00:00","duplicate_cluster_key":"id:nct07828886","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-01 to 2030-09-30","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:15:06.068Z","intervention":[],"participants":300,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Net Clinical Benefit at Week 52 — 52 Weeks","Steroid-Free Clinical Remission at Week 26 — 26 Weeks","Steroid-Free Clinical Remission at Week 52 — 52 weeks","Advanced Therapy Persistence at Week 52 — 52 weeks","Incidence of Serious Infection — From Baseline Through Week 52","Incidence of IBD-Related Hospitalization — From Baseline Through Week 52","Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 26 — Baseline and Week 26","Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 52 — Baseline and Week 52","Change From Baseline in Clinical Frailty Scale Score at Week 52 — Baseline and Week 52"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"immune-aging","is_published":true,"match_reasons":["Title contains controlled term: immune aging.","Abstract contains controlled term: immune aging.","Source terminology contains: immunosenescence.","Title supplies longevity context: aging, older adult.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Immune ageing","slug":"immune-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/9659","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}