Hematopoietic and Lymphoid Cell NeoplasmCATCHNCT04188912
Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
An observational study of Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Biospecimen Collection, Optical Coherence Tomography and Spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 267 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Sep 2019to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for allogeneic hematopoietic cell transplantation (HCT) from any donor for any indication, with a risk of cGVHD of > 25%
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
National Cancer Institute
Bethesda, Maryland, 20892
Roswell Park
Buffalo, New York, 14263
Cleveland Clinic
Cleveland, Ohio, 44195
University of Florida
Gainesville, Florida, 32610
Vanderbilt
Nashville, Tennessee, 37212
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Close Assessment and Testing for Chronic GVHD (The 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.
Read the 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Biospecimen Collection, Optical Coherence Tomography, Spirometry, Survey Administration, Digital Photography
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
Optical Coherence TomographyProcedure or surgery
Also called OCT
Undergo optical coherence tomography
SpirometryProcedure or surgery
Undergo portable spirometry
Survey AdministrationOther
Complete survey
Digital PhotographyOther
Undergo digital photography
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Medical Chart ReviewOther
Also called Chart Review
Review of medical charts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Optical Coherence Tomography; Procedure: Spirometry; Other: Survey Administration; Other: Digital Photography; Other: Quality-of-Life Assessment; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start13 Sep 2019
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephanie Lee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188912
- Sponsor's protocol ID
- RG1005155
- Other IDs
- NCI-2019-07293, 10134, U01CA236229
- Acronym
- CATCH
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pidala J, Hamilton BK, Chen GL, Onstad L, Pavletic SZ, Carpenter PA, Lee CJ, Kitko CL, Farhadfar N, Hall AM, Mays J, Lee SJ. Chronic GVHD consortium CATCH study: incidence, initial presentation, and risk factors for chronic GVHD development. Blood Adv. 2026 Oct 13;10(19):6852-6859. doi: 10.1182/bloodadvances.2026021346.
PubMed 42486676Pidala 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.
PubMed 38753616
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Close Assessment and Testing for Chronic GVHD (The CATCH Study)
- ClinicalTrials.gov ID
- NCT04188912
- Acronym / sponsor ID
- CATCH / RG1005155
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (sample collection, survey, imaging, spirometry) | – | Procedure: Biospecimen Collection, Procedure: Optical Coherence Tomography, Procedure: Spirometry, Other: Survey Administration, Other: Digital Photography, Other: Quality-of-Life Assessment, Other: Medical Chart ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for allogeneic hematopoietic cell transplantation (HCT) from any donor for any indication, with a risk of cGVHD of > 25%
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples | Procedure or surgery | Observational (sample collection, survey, imaging, spirometry) |
| Optical Coherence TomographyAlso: OCTUndergo optical coherence tomography | Procedure or surgery | Observational (sample collection, survey, imaging, spirometry) |
| SpirometryUndergo portable spirometry | Procedure or surgery | Observational (sample collection, survey, imaging, spirometry) |
| Survey AdministrationComplete survey | Other | Observational (sample collection, survey, imaging, spirometry) |
| Digital PhotographyUndergo digital photography | Other | Observational (sample collection, survey, imaging, spirometry) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (sample collection, survey, imaging, spirometry) |
| Medical Chart ReviewAlso: Chart ReviewReview of medical charts | Other | Observational (sample collection, survey, imaging, spirometry) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 42486676Pidala J, Hamilton BK, Chen GL, Onstad L, Pavletic SZ, Carpenter PA, Lee CJ, Kitko CL, Farhadfar N, Hall AM, Mays J, Lee SJ. Chronic GVHD consortium CATCH study: incidence, initial presentation, and risk factors for chronic GVHD development. Blood Adv. 2026 Oct 13;10(19):6852-6859. doi: 10.1182/bloodadvances.2026021346.
- Derived from this study: PubMed 38753616Pidala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lee principal investigator
Fred Hutch/University of Washington Cancer Consortium
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of cytokines (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.