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NCT Number: NCT04168788

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

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.

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Key information

Conditions

Hepatic Veno-Occlusive Disease Acute Lymphoblastic Leukemia Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Lymphoid Liver Diseases Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Nephroblastoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Wilms Tumor

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univesity Hostipal of Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test for genetic analysis

Other

Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Primary outcomes

  1. Correlate pharmacogenetic analysis with veno-occlusive disease.

    Time frame: 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 outcomes

  1. Participant characteristics.

    Time frame: One day

    Age, sociodemographics, personal and cancer history.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: MVO

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2019
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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