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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04431479
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 29, 2020
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Clinical Response according to the 2014 criteria [ Time Frame: Up to 6 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610-
Moffitt Cancer CenterTampaFlorida33612
Joseph Pidala
[email protected]
888-663-3488
Joseph Pidala (PRINCIPAL_INVESTIGATOR)
Dana-Farber Harvard Cancer CenterBostonMassachusetts02115
Corey S. Cutler
[email protected]
617-632-5946
Corey S. Cutler (PRINCIPAL_INVESTIGATOR)
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Roswell Park Cancer InstituteBuffaloNew York14263-
Cleveland Clinic FoundationClevelandOhio44195
Betty K. Hamilton
[email protected]
216-444-6833
Betty K. Hamilton (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Gaby Desatnik
[email protected]
206-667-1356
Stephanie J. Lee (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FLMoffitt Cancer Center· Tampa, FLDana-Farber Harvard Cancer Center· Boston, MAUniversity of Minnesota/Masonic Cancer Center· Minneapolis, MNRoswell Park Cancer Institute· Buffalo, NYCleveland Clinic Foundation· Cleveland, OH

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