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

Fred Hutchinson Cancer Center (FHCC)

Status: Enrolling

Conditions: Chronic Graft Versus Host Disease

Treatments: Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Medical Chart Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04431479

RG1006823

R01CA118953 (U.S. NIH Grant/Contract)

NCI-2020-01242 (Registry Identifier)

10360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Uncontrolled psychiatric disorder
• Anticipated survival < 6 months

Trial design

300 participants in 1 patient group

Observational (questionnaire, biospecimen, chart review)

Description:

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.

Treatment:

Other: Medical Chart Review

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Other: Quality-of-Life Assessment