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

University Hospital, Angers

Status

Unknown

Conditions

Nephroblastoma

Acute Lymphoblastic Leukemia

Hepatic Veno-Occlusive Disease

Treatments

Other: Blood test for genetic analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT04168788

49RC19_0197

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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