NCT04168788

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Veno-Occlusive Disease
• Nephroblastoma
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Blood test for genetic analysis	Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2019-11-19
• Last updated: 2019-11-19

Locations

16 sites across 1 country: France