RecruitingNCT04431479

Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study

Predicting the Quality of Response to Specific Treatments (PQRST)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

300 participants

Start Date

Jun 29, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • Inability to comply with study procedures
  • Uncontrolled psychiatric disorder
  • Anticipated survival < 6 months

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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 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

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NCT04431479


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