Predicting the Quality of Response to Specific Treatments (PQRST)
Fred Hutchinson Cancer Center
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 therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.
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 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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood sample
- OtherMedical Chart Review
Review of medical chart
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Complete questionnaire
Locations (10)
- University of FloridaGainesville, Florida
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Harvard Cancer CenterBoston, Massachusetts
- University of Minnesota/Masonic Cancer CenterMinneapolis, Minnesota
- Roswell Park Cancer InstituteBuffalo, New York
- Cleveland Clinic FoundationCleveland, Ohio