Recruiting NCT05919511
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional.
- Who it may be relevant to
- Registry conditions: cGVHD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
Overview
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
Interventions
- Other Non-Interventional
This is an observational study
Primary outcome measures
- Overall Burden of cGVHD diagnosis and severity [Time frame: 36 months]
Secondary outcome measures (2)
- To describe personal and healthcare resources associated with the management of cGVHD [Time frame: 36 months]
- To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years inclusive at the time of signing the ICF
- Allogeneic SCT 90 to 180 days prior to enrollment
- Able to comprehend and willing to provide informed consent
- Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
Exclusion criteria
- There are no exclusion criteria for this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 32 centers
- University of Alabama Birmingham — Birmingham
- Mayo Clinic Arizona — Phoenix
- City of Hope — Duarte
- USC Norris Comprehensive Cancer Center — Los Angeles
- University of Colorado — Aurora
- Mayo Clinic Jacksonville — Jacksonville
- AdventHealth Orlando — Orlando
- Moffit Cancer Center — Orlando
- … and 24 more centers
Identifiers
NCT: NCT05919511 · MA-GVHD-401