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

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ClinicalTrials.gov Identifier: NCT04188912
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment
Hematopoietic and Lymphoid Cell Neoplasm Procedure: Biospecimen Collection Procedure: Optical Coherence Tomography Procedure: Spirometry Other: Survey Administration Other: Digital Photography Other: Quality-of-Life Assessment Other: Medical Chart Review

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Close Assessment and Testing for Chronic GVHD (The CATCH Study)
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024


Group/Cohort Intervention/treatment
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
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples

Procedure: Optical Coherence Tomography
Undergo optical coherence tomography
Other Name: OCT

Procedure: Spirometry
Undergo portable spirometry

Other: Survey Administration
Complete survey

Other: Digital Photography
Undergo digital photography

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Medical Chart Review
Review of medical charts
Other Name: Chart Review




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood, tissue, saliva, tears, buccal mucosa, feces


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188912


Contacts
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Contact: Marcie Hall 206-667-7010 amhall@fredhutch.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Joseph Pidala    813-745-2556    joseph.pidala@moffitt.org   
Principal Investigator: Joseph Pidala         
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Steven Pavletic    240-760-6174    pavletis@mail.nih.gov   
Principal Investigator: Steven Pavletic         
United States, New York
Roswell Park Recruiting
Buffalo, New York, United States, 14263
Contact: George Chen    716-845-8722    George.chen@roswellpark.org   
Principal Investigator: George Chen         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Betty Hamilton    216-445-7580    hamiltb2@ccf.org   
Principal Investigator: Betty Hamilton         
United States, Tennessee
Vanderbilt Not yet recruiting
Nashville, Tennessee, United States, 37212
Contact: Carrie Kitko    615-936-1762    carrie.l.kitko@vumc.org   
Principal Investigator: Carrie Kitko         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Marcie Hall    206-667-7010    amhall@fredhutch.org   
Principal Investigator: Stephanie Lee         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Stephanie Lee Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04188912    
Other Study ID Numbers: RG1005155
NCI-2019-07293 ( Registry Identifier: NCI / CTRP )
10134 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
U01CA236229 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases