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NCT Number: NCT04188912

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

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples

Optical Coherence Tomography

Procedure

Undergo optical coherence tomography

Other names: OCT

Spirometry

Procedure

Undergo portable spirometry

Survey Administration

Other

Complete survey

Digital Photography

Other

Undergo digital photography

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

medical chart review

Other

Review of medical charts

Other names: Chart Review

Primary outcomes

  1. Levels of cytokines

    Time frame: Up to 3 years

    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.

  2. Onset of cGVHD

    Time frame: Up to 3 years

    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.

  3. Percentage of cellular populations

    Time frame: Up to 3 years

    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.

  4. Number of patients with tissue alterations in skin, mouth and eyes

    Time frame: Up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: CATCH

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2019
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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