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Brief Title: Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
Official Title: Close Assessment and Testing for Chronic GVHD (The CATCH Study)
Study ID: NCT04188912
Brief Summary: This trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (GVHD) develops after stem cell transplantation. Performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic GVHD.
Detailed Description: OUTLINE: Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed. After completion of study, patients are followed up periodically.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Florida, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
National Cancer Institute, Bethesda, Maryland, United States
Roswell Park, Buffalo, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Vanderbilt, Nashville, Tennessee, United States
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Name: Stephanie Lee
Affiliation: Fred Hutch/University of Washington Cancer Consortium
Role: PRINCIPAL_INVESTIGATOR