Study protocol: Close Assessment and Testing for Chronic Graft-vs.-Host disease (CATCH).

Chronic graft-versus-host disease (GVHD) is an immune-mediated disorder that causes significant late morbidity and mortality following allogeneic hematopoietic cell transplantation. The "Close Assessment and Testing for Chronic GVHD (CATCH)" study is a multi-center Chronic GVHD Consortium prospective, longitudinal cohort study designed to enroll patients before hematopoietic cell transplantation and follow them closely to capture the development of chronic GVHD and to identify clinical and biologic biomarkers of chronic GVHD onset. Data are collected pre-transplant and every two months through one-year post-transplant with chart review thereafter. Evaluations include clinician assessment of chronic GVHD and its manifestations, patient-reported outcomes, multiple biospecimens (blood, saliva, tears, buccal mucosa and fecal samples, biopsies of skin and mouth), laboratory testing, and medical record abstraction. This report describes the rationale, design, and methods of the CATCH study, and invites collaboration with other investigators to leverage this resource. trial registration: This study is registered at www.clinicaltrials.gov as NCT04188912.

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Déclaration de conflit d'intérêts

JP has been a consultant and advisory board member for Syndax, CTI Biopharma, Amgen, Regeneron, Incyte. He has received clinical trial support from Novartis, Amgen, Takeda, Janssen, Johnson and Johnson, Pharmacyclics, Abbvie, CTI Biopharma, and Bristol Myers Squibb. SZP received research support from the Center for Cancer Research at the National Cancer Institute through the National Institutes of Health Intramural Research Program, which includes Clinical Research Development Agreements with Celgene, Actelion, Eli Lilly, Pharmacyclics and Kadmon Corporation. NF Incyte Advisory Board SJL has received consulting fees from Mallinckrodt, Equillium, Kadmon, Novartis and Incyte; research funding from Amgen, AstraZeneca, Incyte, Kadmon, Novartis, Pfizer, Sanofi, Syndax and Takeda, and drug supply from Janssen. She is on Incyte and Sanofi clinical trial steering committees. This does not alter our adherence to PLOS ONE policies on sharing data and materials.