Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
NCT ID: NCT04431479
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2020-06-29
2026-08-02
Brief Summary
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Detailed Description
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Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (questionnaire, biospecimen, chart review)
Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.
Biospecimen Collection
Undergo collection of blood sample
Medical Chart Review
Review of medical chart
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaire
Interventions
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Biospecimen Collection
Undergo collection of blood sample
Medical Chart Review
Review of medical chart
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
* No evidence of persistent or progressive malignancy at the time of enrollment
* Agrees to be evaluated at the transplant center before a new line of treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after index treatment is started or if an additional new therapy is started before 6 months
* Signed, informed consent
Exclusion Criteria
* Uncontrolled psychiatric disorder
* Anticipated survival \< 6 months
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Stephanie J. Lee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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University of Florida
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Vancouver General Hospital/BC Cancer
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Hamilton BK, Onstad L, Carpenter PA, Pidala J, El Jurdi N, Farhadfar N, Kitko CL, Lee CJ, Mehta R, Chen GL, Cutler C, Lee SJ. Study Protocol: Predicting the Quality of Response to Specific Treatments (PQRST) in Chronic Graft-versus-Host Disease. Contemp Clin Trials. 2024 Oct;145:107637. doi: 10.1016/j.cct.2024.107637. Epub 2024 Jul 20.
Other Identifiers
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NCI-2020-01242
Identifier Type: REGISTRY
Identifier Source: secondary_id
10360
Identifier Type: OTHER
Identifier Source: secondary_id
RG1006823
Identifier Type: -
Identifier Source: org_study_id
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