Cancer Clinical Trial
— MVOOfficial title:
Pharmacogenetics of Veno-Occlusive Disease (VOD) in Children With Haematological Stem Cell Transplantation (HSCT)
NCT number | NCT03664427 |
Other study ID # | NI16025J |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 15, 2019 |
Est. completion date | January 15, 2021 |
Verified date | October 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 436 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility | Inclusion Criteria: - Children with cancer aged less than 18 years old treated for their first HSCT between 2000 and 2011 in France. - Patients are selected from the database ProMise regarding pediatric patients treated in any center of the French Society of Stem Cell transplantation (SFGM). - Clinical data (age, sex, initial pathology, conditioning treatment, type of graft cells, VOD occurence or not, survival status at 100 days and 1 year after transplantation) were extracted from this database. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
France | Robert Debre Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacogenetic biomarkers | 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). | 12 months | |
Secondary | Survival status at 100 days post HSCT | Survival at 100 days post-HSCT will be evaluated according to the occurrence or not of VOD | 100 days | |
Secondary | Survival status at 1 year post HSCT | Survival at 1 year post-HSCT will be evaluated according to the occurrence or not of VOD | 12 months |
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