ABLE-cGVHD
Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Canadian Institutes of Health Research
observational
302
3 countries
25
Study Start
November 2013
Actual (reported)Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Actual (reported)January 20, 2014
Actual (reported)February 20, 2014
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
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
Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months
Validation of "predictive" cGVHD bio-markers
Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)
Recipients and donors of allogeneic hematopoietic stem cell transplantation
Children's of Alabama
Birmingham, Alabama, 35233, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
Nemours A. I. DuPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Nemours Children's Clinic
Cuvelier GDE, Ng B, Abdossamadi S, Nemecek ER, Melton A, Kitko CL, Lewis VA, Schechter T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Chaudhury S, Coulter D, Chewning JH, Joyce M, Savasan S, Pawlowska AB, Megason GC, Mitchell D, Cheerva AC, Lawitschka A, Ostroumov E, Schultz KR. A diagnostic classifier for pediatric chronic graft-versus-host disease: results of the ABLE/PBMTC 1202 study. Blood Adv. 2023 Jul 25;7(14):3612-3623. doi: 10.1182/bloodadvances.2022007715.
Subburaj D, Ng B, Kariminia A, Abdossamadi S, Lauener M, Nemecek ER, Rozmus J, Kharbanda S, Kitko CL, Lewis VA, Schechter-Finklestein T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Coulter D, Chewning JH, Joyce M, Pawlowska AB, Megason GC, Lawitschka A, Ostroumov E, Klein Geltink R, Cuvelier GDE, Schultz KR. Metabolomic identification of alpha-ketoglutaric acid elevation in pediatric chronic graft-versus-host disease. Blood. 2022 Jan 13;139(2):287-299. doi: 10.1182/blood.2021013244.
From recipient: whole blood From donor: bone marrow or apheresis product
Geoff Cuvelier, MD
University of Manitoba
Kirk R Schultz, MD
University of British Columbia
302 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2014
First Posted
February 20, 2014
Study Start
November 2013
Actual (reported)Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease
Contact the study team to confirm eligibility.
Jacksonville, Florida, 32207, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605, United States
C S Mott Children's Hospital The University of Michigan
Ann Arbor, Michigan, 48109-1274, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Blair E. Batson Hospital for Children
Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7140, United States
Morgan Stanley Children's Hospital
New York, New York, 10032, United States
New York Medical College
Valhalla, New York, 10595, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Utah Primary Children's Medical Center
Salt Lake City, Utah, 84132, United States
ST.Anna Children's Hospital
Vienna, Austria
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
University of British Columbia - BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
University of Manitoba
Winnipeg, Manitoba, R3T 2N2, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3, Canada
The Sainte-Justine University Hospital Centre
Montreal, Quebec, H3T 1C5, Canada
Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2023
Record last verified: 2023-12
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