Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study (CATCH)
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| ClinicalTrials.gov Identifier: NCT04188912 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2019
Last Update Posted : February 21, 2021
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Sponsor:
Fred Hutchinson Cancer Research Center
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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 :
- 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.
- 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.
- 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.
- 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
| Contact: Marcie Hall | 206-667-7010 | amhall@fredhutch.org |
Locations
| 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
| Principal Investigator: | Stephanie Lee | Fred Hutch/University of Washington Cancer Consortium |
| 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 |
| 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 |