Clinical trial NCT05919511: Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
Official title: A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: cGVHD
Keywords: chronic graft versus host disease
cGVHD
MA-GVHD-401
THRIVE
GVHD
chronic GVHD
allogenic stem cell transplant (alloSCT)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants greater than or equal to 18 years of age who have had Allogenic SCT 90 to 180 days prior to enrollment

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)


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

Primary outcomes:
measure: Overall Burden of cGVHD diagnosis and severity
timeFrame: 36 months
Secondary outcomes:
measure: To describe personal and healthcare resources associated with the management of cGVHD
timeFrame: 36 months
measure: To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Group
state: Illinois
city: Fairway
country: United States
facility: The University of Kansas Clinical Research Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts Cancer Research Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: