Clinical trial · Observational
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
Close Assessment and Testing for Chronic GVHD (The CATCH Study)
NCT04188912CI-TRIAL-00096160CATCHcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Digital Photography | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Optical Coherence Tomography | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Spirometry | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (sample collection, survey, imaging, spirometry)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Optical Coherence Tomography
- Procedure: Spirometry
- Other: Survey Administration
- Other: Digital Photography
- Other: Quality-of-Life Assessment
- Other: Medical Chart Review
Primary outcomes (4)
- measure
- Levels of cytokines
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults age 18 or older * Scheduled for allogeneic HCT from any donor for any indication, with a risk of cGVHD of \> 25% (see below in exclusion criteria for treatment plans with a cGVHD risk \< 25%) * Ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site * Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDPidala 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. PMID 38753616