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Published on: February 11, 2019
Study protocol: Close Assessment and Testing for Chronic Graft-vs.-Host disease (CATCH)
Joseph Pidala1, Paul A Carpenter2,3, Lynn Onstad2
1Department of Blood and Marrow Transplantation and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL, United States of America.
Insights
The Close Assessment and Testing for Chronic GVHD (CATCH) study aims to identify biomarkers for chronic graft-versus-host disease (GVHD) after transplantation. This research will improve understanding and management of this serious immune complication.
Area of Science:
- Immunology
- Transplantation Medicine
- Biomarker Discovery
Background:
- Chronic graft-versus-host disease (GVHD) is a significant complication following allogeneic hematopoietic cell transplantation.
- It leads to substantial late morbidity and mortality in transplant recipients.
Purpose of the Study:
- To prospectively identify clinical and biologic biomarkers for chronic GVHD onset.
- To closely monitor patients pre- and post-transplant to capture GVHD development.
- To facilitate collaboration for leveraging the CATCH study resource.
Main Methods:
- Prospective, multi-center, longitudinal cohort study design.
- Enrollment of patients before hematopoietic cell transplantation.
- Collection of comprehensive data including clinical assessments, patient-reported outcomes, biospecimens (blood, saliva, etc.), laboratory tests, and medical records.
- Data collection at baseline, every two months for one year, and ongoing chart review.
Main Results:
- This report focuses on the study's rationale, design, and methods.
- Detailed findings on biomarker identification and clinical outcomes will be reported as the study progresses.
Conclusions:
- The CATCH study provides a robust framework for understanding chronic GVHD.
- The study aims to improve early detection and management strategies for chronic GVHD.
- Collaboration is encouraged to maximize the impact of this research resource.
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.
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