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

PLoS One. 2024 May 16;19(5):e0298026. doi: 10.1371/journal.pone.0298026. eCollection 2024.

Abstract

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.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Biomarkers
  • Chronic Disease
  • Female
  • Graft vs Host Disease* / diagnosis
  • Graft vs Host Disease* / etiology
  • Hematopoietic Stem Cell Transplantation* / adverse effects
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Prospective Studies
  • Transplantation, Homologous

Substances

  • Biomarkers

Associated data

  • ClinicalTrials.gov/NCT04188912

Grants and funding

National Institutes of Health CA236229 (SJL, SZP)