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

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Fred Hutchinson Cancer Research Center
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Updated on 5 August 2020
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cancer
stem cell transplantation
graft versus host disease
second-line therapy

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 initial or second-line 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

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.

Details
Condition Chronic Graft Versus Host Disease
Age 18years - 100years
Treatment Questionnaire Administration, Quality-of-Life Assessment, Biospecimen Collection, Medical Chart Review
Clinical Study IdentifierNCT04431479
SponsorFred Hutchinson Cancer Research Center
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 initial or second-line treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after treatment is started or if a 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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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