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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Optical Coherence Tomography
* Procedure: Spirometry
* Other: Survey Administration
* Other: Digital Photography
* Other: Quality-of-Life Assessment
* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (sample collection, survey, imaging, spirometry)<br>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. | Procedure: Biospecimen Collection<br>* Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples<br>Procedure: Optical Coherence Tomography<br>* Undergo optical coherence tomography<br>* Other names: OCT;Procedure: Spirometry<br>* Undergo portable spirometry<br>Other: Survey Administration<br>* Complete survey<br>Other: Digital Photography<br>* Undergo digital photography<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Medical Chart Review<br>* Review of medical charts<br>* Other names: Chart Review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of cytokines | Will compare the pg/ml levels and trajectories of proteins (IL-1b; IL-4; IL-5; IL-6; IL-8; IL-10; IL-13; IL-17a (pg/mL); TNF; G-CSF; IFNgamma; MCP-1; IL-12p40; GM-CSF; IL-2) between patients who do and do not develop chronic graft versus host disease (cGVHD). Blood will be analyzed separately from saliva and conjunctival washings. | Up to 3 years | 
| Onset of cGVHD | Onset of cGVHD will be treated as a time-to-event endpoint, using Cox regression with monthly levels or slopes of the markers entered as time dependent covariates. | Up to 3 years | 
| Percentage of cellular populations | Will compare the levels, proportions and trajectories of different cellular populations between those with and without cGVHD, and with different cGVHD organ involvement and symptoms. The following cell subtypes are of highest interest: Th17, FOXP3+ T regulatory cells, FOXP3- T regulatory type 1 (TR1) cells, T follicular helper cells, activated B cells, B regulatory cells, and monocytes but the list may evolve before actual testing. | Up to 3 years | 
| Number of patients with tissue alterations in skin, mouth and eyes | Tissue alterations will be classified into Abnormal and Normal, and measured by biopsy and/or advanced bioimaging techniques. Histologic findings, ribonucleic acid (RNA) expression profiles, optical coherence tomography (OCT) findings and digital image interpretations will be compared between patients who do and do not develop cGVHD or who have different cGVHD clinical phenotypes and symptoms. | Up to 3 years |