Status:
RECRUITING
Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Brief Summary
This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new th...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Inability to comply with study procedures
- Uncontrolled psychiatric disorder
- Anticipated survival \< 6 months
Key Trial Info
Start Date :
June 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 2 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04431479
Start Date
June 29 2020
End Date
August 2 2026
Last Update
November 19 2025
Active Locations (10)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, United States, 02115
4
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455