Pharmacogenetics of VOD in Children With HSCT (MVO)
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|ClinicalTrials.gov Identifier: NCT03664427|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : February 5, 2019
This project aims to identify common pharmacogenetic biomarkers predisposing children with cancer to develop hepatic VOD during their cancer treatment including HSCT. The impact of VOD occurrence and significant biomarkers will also be evaluated on outcome at day 100 and one year after HSCT. It should help to highlight factors that can contribute to the initiation of hepatic VOD.
Understanding mechanisms of this toxicity and to know individual parameters of disease susceptibility becomes an important issue in the care of these children. The ultimate goal of research in this area would be to develop a personalized predictive medicine and, hopefully, prevent the occurrence of VOD from a therapeutic adaptation to each patient according to his pharmacogenetic profile (adapted prophylaxis, dose adjustment, drug combinations ...). A prospective identification of patients at risk of hepatic VOD will increase the safe use of anticancer.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||436 participants|
|Official Title:||Pharmacogenetics of Veno-Occlusive Disease (VOD) in Children With Haematological Stem Cell Transplantation (HSCT)|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||January 15, 2021|
Group 1: Patients with VOD
paediatric patients with Veno-Occlusive Disease (VOD) complicating haematological stem cell transplantation
Group 2: matched controls
Paediatric patients defined as matched controls without veno-occlusive disease complicating haematological stem cell transplantation
- Pharmacogenetic biomarkers [ Time Frame: 12 months ]The pharmacogenetic analysis will be conducted by a whole exome genotyping approach with Microarrays Illumina "Human Omni2.5-8 v1.3" (exploring more than 2,600,000 genetic variants covering the entire genome with more than 300,000 genetic biomarkers within exons).
- Survival status at 100 days post HSCT [ Time Frame: 100 days ]Survival at 100 days post-HSCT will be evaluated according to the occurrence or not of VOD
- Survival status at 1 year post HSCT [ Time Frame: 12 months ]Survival at 1 year post-HSCT will be evaluated according to the occurrence or not of VOD
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): NCT03664427
|Contact: Evelyne Jacqz-Aigrain, MD, PhD||+33(0)firstname.lastname@example.org|
|Contact: Jean-Hugues Dalle, MD, PhD||+33 (0) 40 03 12 email@example.com|
|Robert Debre Hospital||Recruiting|
|Paris, France, 75019|
|Contact: Tiphaine Debeaumais, PharmD, PhD +33(0)140032150 firstname.lastname@example.org|