NCT07828886Toborzás még nem indult
Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD
Immunosenescence Phenotypes and Net Clinical Benefit of Advanced Therapies in Older Adults With Inflammatory Bowel Disease: A Prospective Multicenter Observational Cohort Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 300 (tervezett)
- Első benyújtás
- 2026. szept. 7.
- Kezdés
- 2026. okt. 12.
- Elsődleges befejezés
- 2029. szept. 30.
- Fő szponzor
- First Affiliated Hospital, Sun Yat-Sen University
- Betegségek
- Crohn-betegség, Colitis ulcerosa
- NCT-szám
- NCT07828886
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 300
- 2026. okt. 12. és az elsődleges befejezés (2029. szept. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Significant acute infection within 4 weeks before enrollment that, in the investigator's judgment, could substantially affect baseline immune-aging measurements or treatment safety assessment.
- Treatment with the same index advanced therapy for more than 4 weeks before enrollment.
Más betegség
- Uncertain diagnosis of inflammatory bowel disease or an alternative diagnosis that may mimic inflammatory bowel disease.
- Active severe infection at enrollment, including sepsis, active tuberculosis, uncontrolled viral hepatitis, cytomegalovirus disease, or another serious opportunistic infection.
- Active malignancy or recent systemic anticancer treatment, except for adequately treated low-risk malignancies as permitted by the study protocol.
- Severe non-IBD-related immunodeficiency. End-stage disease or another condition associated with an expected life expectancy of less than 12 months.
- Any other condition that, in the investigator's judgment, would make participation inappropriate or prevent adequate follow-up.
Egyéb
- Inability to obtain the core baseline variables required for the primary analyses.
- Participation in an interventional clinical trial that could interfere with the study assessments or outcomes.
Kiket keres a vizsgálat
- Age 60 years or older. Confirmed diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified.
- Planned initiation of a new advanced therapy, or initiation of the new advanced therapy within 4 weeks before enrollment.
- Active inflammatory bowel disease or another clinically documented indication for treatment escalation.
- Availability of the core baseline clinical and laboratory data required for the study.
- Expected 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.
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