Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 302
- 试验地点
- 25
- 主要终点
- Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.
- •Age 0-17.99 years at the time of transplantation.
- •Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
- •Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
- •Use of serotherapy is permitted.
- •Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.
- •If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.
- •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.
- •Written informed consent from parents.
- •Assent from study participant when appropriate.
- •Participation on other clinical trials is acceptable.
排除标准
- •Autologous HSCT.
- •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.
- •Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
- •Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
- •Syngeneic transplants.
结局指标
主要结局
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
时间窗: 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
次要结局
- 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))
研究者
Kirk Schultz
Principle Investigator
University of British Columbia