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Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
NCT04431479 · Fred Hutchinson Cancer Center
In plain English
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Official title
Predicting the Quality of Response to Specific Treatments (PQRST)
About this study
OUTLINE: This is an observational study.
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.
Eligibility criteria
Inclusion Criteria:
* Adults age 18 or older
* 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:
* Inability to comply with study procedures
* Uncontrolled psychiatric disorder
* Anticipated survival \< 6 months
Study design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-06-29
Estimated completion: 2026-08-02
Last updated: 2025-11-19
Interventions
Procedure: Biospecimen CollectionOther: Medical Chart ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Primary outcomes
- • Clinical Response according to the 2014 criteria (Up to 6 months)
- • Time to next systemic treatment (From the start of the index medication until the addition of another systemic chronic graft versus host disease (cGVHD) treatment with death and treated recurrent malignancy considered competing events, assessed up to 3 years)
- • Duration of treatment (Up to 3 months)
Sponsor
Fred Hutchinson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactGaby Desatnik · contact · cgvhd@fredhutch.org · 206-667-1356
InvestigatorStephanie J. Lee · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (10)
University of FloridaCompleted
Gainesville, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Dana-Farber Harvard Cancer CenterRecruiting
Boston, Massachusetts, United States
University of Minnesota/Masonic Cancer CenterCompleted
Minneapolis, Minnesota, United States
Roswell Park Cancer InstituteCompleted
Buffalo, New York, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
UPMC Hillman Cancer CenterCompleted
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer CenterCompleted
Nashville, Tennessee, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States
Vancouver General Hospital/BC CancerCompleted
Vancouver, British Columbia, Canada