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

Not Applicable

Conditions: Hepatic Veno-Occlusive Disease
Nephroblastoma
Acute Lymphoblastic Leukemia

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nephrobalstoma or ALL	Blood test for genetic analysis	Pateints treated for a nephrobalstoma or ALL in childhood or adolescence

Primary Outcome Measures

Name	Time	Method
Correlate pharmacogenetic analysis with veno-occlusive disease.	One day	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.

Secondary Outcome Measures

Name	Time	Method
Participant characteristics.	One day	Age, sociodemographics, personal and cancer history.

Locations (16): University Hospital of Bordeaux
🇫🇷
Bordeaux, France
Centre Oscar Lambret
🇫🇷
Lille, France
University Hospital of Nantes
🇫🇷
Nantes, France
University Hospital of Nice
🇫🇷
Nice, France
Hôpital Trousseau
🇫🇷
Paris, France
University Hospital of Poitiers
🇫🇷
Poitiers, France
University Hospital of Tours
🇫🇷
Tours, France
Univesity Hostipal of Amiens
🇫🇷
Amiens, France
University of Brest
🇫🇷
Brest, France
University Hospital of Dijon
🇫🇷
Dijon, France
University Hospital of Limoges
🇫🇷
Limoges, France
Hôpital La Timone
🇫🇷
Marseille, France
University Hospital of Rennes
🇫🇷
Rennes, France
University Hospital of La Réunion
🇫🇷
Saint-Denis, France
Gustave Roussy
🇫🇷
Villejuif, France
Institut Curie
🇫🇷
Paris, France