Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL

Study Overview
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Brief Summary
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Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children. The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

Detailed Description
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Case-control study, nested in two French multicenter cohorts, on pharmacognenetic, biological and clinical susceptibility factors associated with the occurrence of hepatic veno-occlusive disease during the anticancer treatment for nephroblastoma or acute lymphoblastic leukemia, with centralized genetic analysis. After obtaining consent (patient or parents for minor patients), a blood sample is collected during the routine follow-up consultation and tubes are sent directly to Paris for the pharmacogenetic analysis at the end of the study.

Official Title
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Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia

Conditions
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Hepatic Veno-Occlusive Disease, Nephroblastoma, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Other: Blood test for genetic analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged < 18 years old at the time of cancer diagnosis Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation Weight greater than 5 kg at inclusion Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study Affiliated to a Social Security scheme Exclusion Criteria: Unavaibility of constitutional DNA Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence Pregnant, lactating or parturient women Person deprived of their liberty by judicial or administrative decision Person under psychiatric care under duress Person subject to legal protection Person unable to express their consent

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nephrobalstoma or ALL<br>Pateints treated for a nephrobalstoma or ALL in childhood or adolescence | Other: Blood test for genetic analysis<br>* Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate pharmacogenetic analysis with veno-occlusive disease. | Illumina's Human Omni2.5-8 v1.3 microarrays explore more than 2,600,000 genetic variants, thus covering the entire genome with more than 300,000 genetic biomarkers in exons. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant characteristics. | Age, sociodemographics, personal and cancer history. | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenetics