Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
NCT ID: NCT04188912
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
267 participants
OBSERVATIONAL
2019-09-13
2025-09-29
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (sample collection, survey, imaging, spirometry)
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 tomography before 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.
Biospecimen Collection
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
Optical Coherence Tomography
Undergo optical coherence tomography
Spirometry
Undergo portable spirometry
Survey Administration
Complete survey
Digital Photography
Undergo digital photography
Quality-of-Life Assessment
Ancillary studies
Medical Chart Review
Review of medical charts
Interventions
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Biospecimen Collection
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
Optical Coherence Tomography
Undergo optical coherence tomography
Spirometry
Undergo portable spirometry
Survey Administration
Complete survey
Digital Photography
Undergo digital photography
Quality-of-Life Assessment
Ancillary studies
Medical Chart Review
Review of medical charts
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team
* Receipt of umbilical cord blood, bone marrow with post-transplant cyclophosphamide (peripheral blood with post-transplant cyclophosphamide is allowed), anti-thymocyte globulin, alemtuzumab, or ex-vivo T-cell depletion. These patients are excluded because they have a cGVHD risk of \< 25%
* Hematologic malignancy with active disease at the time of transplant. Minimal residual disease is allowed
* Hematopoietic cell transplant co-morbidity index \> 4 based on parameters known at time of enrollment
* Prior allogeneic transplant
* Prior autoimmune disease with ongoing symptoms
* History of noncompliance
* Inability to comply with study requirements due to geographic, logistic, social or any other factors
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Stephanie Lee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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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
Countries
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References
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Pidala J, Carpenter PA, Onstad L, Pavletic SZ, Hamilton BK, Chen GL, Farhadfar N, Hall M, Lee SJ. 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.
Other Identifiers
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NCI-2019-07293
Identifier Type: REGISTRY
Identifier Source: secondary_id
10134
Identifier Type: OTHER
Identifier Source: secondary_id
RG1005155
Identifier Type: -
Identifier Source: org_study_id
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