NCT04188912

Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study

Close Assessment and Testing for Chronic GVHD (The CATCH Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 267 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
PROCEDURE	Optical Coherence Tomography	Undergo optical coherence tomography
PROCEDURE	Spirometry	Undergo portable spirometry
OTHER	Survey Administration	Complete survey
OTHER	Digital Photography	Undergo digital photography
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Medical Chart Review	Review of medical charts

Timeline

• Start date: 2019-09-13
• Primary completion: 2025-09-29
• Completion: 2025-09-29
• First posted: 2019-12-06
• Last updated: 2025-10-02

Locations

7 sites across 1 country: United States