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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2022

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.

Interventions

  • Other: Blood test for genetic analysis
    • Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Arms, Groups and Cohorts

  • Other: Nephrobalstoma or ALL
    • Pateints treated for a nephrobalstoma or ALL in childhood or adolescence

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Participant characteristics.
    • Time Frame: One day
    • Age, sociodemographics, personal and cancer history.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Isabelle Pellier, MD, Principal Investigator, University Hospital, Angers
  • Overall Contact(s)
    • Denise Jolivot, MD, 33-(0)2-41-35-58-08, DeJolivot@chu-angers.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.