THRIVE: Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
Sponsor
Incyte Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05919511
Collaborator
(none)
1,500
51.6
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
Anticipated Study Start Date
:
Jun 26, 2023
Anticipated Primary Completion Date
:
Oct 15, 2027
Anticipated Study Completion Date
:
Oct 15, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| At risk for GVHD Equal or Greater than 18 years old post alloSCT |
Other: Non-Interventional
This is an observational study
|
Outcome Measures
Primary Outcome Measures
- Overall Burden of cGVHD diagnosis and severity [36 months]
Secondary Outcome Measures
- To describe personal and healthcare resources associated with the management of cGVHD [36 months]
- To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD [Up to 36 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Incyte Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT05919511
Other Study ID Numbers:
- MA-GVHD-401
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Incyte Corporation
Additional relevant MeSH terms: