NCT04431479

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

Predicting the Quality of Response to Specific Treatments (PQRST)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood sample
OTHER	Medical Chart Review	Review of medical chart
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2020-06-29
• Primary completion: 2026-08-02
• Completion: 2026-08-02
• First posted: 2020-06-16
• Last updated: 2025-11-19

Locations

10 sites across 2 countries: United States, Canada