Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059730) titled 'Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions' on Nov. 10.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Yokohama City University Hospital

Condition: Condition - idiopathic pulmonary fibrosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this systematic review is to evaluate the validity of surrogate endpoints in idiopathic pulmonary fibrosis trials by determining which of two endpoint categories better predicts overall survival: (i) exacerbation based endpoints (time to first exacerbation or exacerbation free survival) and (ii) composite survival endpoints (combining death with major clinical events such as hospitalization, physiologic decline, acute exacerbation, or lung transplantation). Specifically, we will assess how the hazard ratios for these endpoints (HR_ex and HR_comp) correlate with the hazard ratio for all cause mortality (HR_OS). Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Population: patients with idiopathic pulmonary fibrosis (IPF).

Diagnostic certainty: possible, probable, or definite IPF will be treated collectively as IPF if permitted by the original study design.

Comorbidities: no restriction; comorbid conditions are not grounds for exclusion.

IPAF: included if diagnosed as IPF and without a confirmed diagnosis of any collagen vascular disease. Key exclusion criteria - Studies that enroll patients with active or ongoing acute exacerbation at baseline.

Studies primarily recruiting non-IPF interstitial lung diseases (e.g., confirmed connective tissue disease-associated ILD).

Non-human, pediatric-only, or non-clinical studies that do not match the target patient population.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 10 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2027 Year 01 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068308

Disclaimer: Curated by HT Syndication.