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

NCT04188912 | Completed

• 4 other identifiers: RG1005155NCI-2019-0729310134U01CA236229
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

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

Interventions

Biospecimen Collection PROCEDURE

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

Observational (sample collection, survey, imaging, spirometry)

Optical Coherence Tomography PROCEDURE

Undergo optical coherence tomography

Also known as: OCT

Observational (sample collection, survey, imaging, spirometry)

Spirometry PROCEDURE

Undergo portable spirometry

Observational (sample collection, survey, imaging, spirometry)

Survey Administration OTHER

Complete survey

Observational (sample collection, survey, imaging, spirometry)

Digital Photography OTHER

Undergo digital photography

Observational (sample collection, survey, imaging, spirometry)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (sample collection, survey, imaging, spirometry)

Medical Chart Review OTHER

Review of medical charts

Also known as: Chart Review

Observational (sample collection, survey, imaging, spirometry)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for allogeneic hematopoietic cell transplantation (HCT) from any donor for any indication, with a risk of cGVHD of \> 25%

You may qualify if:

• Adults age 18 or older

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (7)

University of Florida

Gainesville, Florida, 32610, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt

Nashville, Tennessee, 37212, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 38753616 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue, saliva, tears, buccal mucosa, feces

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Stephanie Lee

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: September 13, 2019
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)