Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease (ABLE-cGVHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02067832|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2014
Last Update Posted : May 7, 2020
Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients.
The research will look into identifying and validating cGVHD biological indicators (=bio-markers) which will be evaluated whether they can predict a future development of the disease.
The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be present at the time of cGVHD diagnosis, will also be present at earlier time points, before cGVHD develops.
Following validation, the bio-markers will be beneficial for finding those patients who are in higher risk to develop cGVHD.
By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive therapy might be applied in order to prevent or reduce the prevalence of the disease.
|Condition or disease|
|Chronic Graft vs Host Disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
- Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients [ Time Frame: Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months ]The study will try to determine the prevalence (or levels) of high-probability predictive plasma and cellular cGVHD bio-markers in pediatric patients undergoing allogeneic HSCT from blood samples
- Validation of "predictive" cGVHD bio-markers [ Time Frame: Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017) ]To determine and validate whether "predictive" cGVHD bio-markers present before the onset of cGVHD are able to predict a subset of pediatric patients at greatest risk for the development of cGVHD in the future
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067832
|Principal Investigator:||Geoff Cuvelier, MD||University of Manitoba|
|Principal Investigator:||Kirk R Schultz, MD||University of British Columbia|