Predicting the Quality of Response to Specific Treatments (PQRST)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Florida
COMPLETED
Gainesville
Moffitt Cancer Center
RECRUITING
Tampa
Massachusetts
Dana-Farber Harvard Cancer Center
RECRUITING
Boston
Minnesota
University of Minnesota/Masonic Cancer Center
ACTIVE_NOT_RECRUITING
Minneapolis
New York
Roswell Park Cancer Institute
COMPLETED
Buffalo
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
UPMC Hillman Cancer Center
COMPLETED
Pittsburgh
Tennessee
Vanderbilt University/Ingram Cancer Center
COMPLETED
Nashville
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Other Locations
Canada
Vancouver General Hospital/BC Cancer
COMPLETED
Vancouver
Contact Information
Primary
Gaby Desatnik
cgvhd@fredhutch.org
206-667-1356
Time Frame
Start Date: 2020-06-29
Estimated Completion Date: 2026-08-02
Participants
Target number of participants: 300
Treatments
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.
Authors
Sponsors
Leads: Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov