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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
Sponsor:
Information provided by (Responsible Party):
Kirk Schultz, University of British Columbia

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
From recipient: whole blood From donor: bone marrow or apheresis product


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recipients and donors of allogeneic hematopoietic stem cell transplantation
Criteria

Inclusion Criteria:

  1. Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.
  2. Age 0-17.99 years at the time of transplantation.
  3. Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
  4. Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
  5. Use of serotherapy is permitted.
  6. Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.
  7. If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.
  8. If participant weighs over 20 kg, participant must be able to provide 1ml/kg of whole blood, up to a maximum of 23 mL for the pre-conditioning sample and 32 mL for samples at day +100, 6-months, 12-months, +/- the cGVHD sample.
  9. Written informed consent from parents.
  10. Assent from study participant when appropriate.
  11. Participation on other clinical trials is acceptable.

Exclusion Criteria:

  1. Autologous HSCT.
  2. Patients referred to a Bone Marrow Transplant (BMT) center from a non-BMT center, where it is anticipated (at the discretion of the center PI) that adequate follow up according to the rules of this protocol can not be met, including the requirement for a reassessment by the BMT center at the time of cGVHD diagnosis.
  3. Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
  4. Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
  5. Syngeneic transplants.

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Geoff Cuvelier, MD University of Manitoba
Principal Investigator: Kirk R Schultz, MD University of British Columbia
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Responsible Party: Kirk Schultz, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02067832    
Other Study ID Numbers: H12-02890
TCF-118695 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases