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

Primary Purpose

Hepatic Veno-Occlusive Disease, Nephroblastoma, Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test for genetic analysis
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Veno-Occlusive Disease focused on measuring Pharmacogenetics

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Univesity Hostipal of Amiens
  • University Hospital of Bordeaux
  • University of Brest
  • University Hospital of Dijon
  • Centre Oscar Lambret
  • University Hospital of Limoges
  • Hôpital La Timone
  • University Hospital of Nantes
  • University Hospital of Nice
  • Institut Curie
  • Hôpital Trousseau
  • University Hospital of Poitiers
  • University Hospital of Rennes
  • University Hospital of La Réunion
  • University Hospital of Tours
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nephrobalstoma or ALL

Arm Description

Pateints treated for a nephrobalstoma or ALL in childhood or adolescence

Outcomes

Primary Outcome Measures

Correlate pharmacogenetic analysis with veno-occlusive disease.
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

Participant characteristics.
Age, sociodemographics, personal and cancer history.

Full Information

First Posted
November 5, 2019
Last Updated
November 15, 2019
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04168788
Brief Title
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL
Acronym
MVO
Official Title
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Veno-Occlusive Disease, Nephroblastoma, Acute Lymphoblastic Leukemia
Keywords
Pharmacogenetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nephrobalstoma or ALL
Arm Type
Other
Arm Description
Pateints treated for a nephrobalstoma or ALL in childhood or adolescence
Intervention Type
Other
Intervention Name(s)
Blood test for genetic analysis
Intervention Description
Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.
Primary Outcome Measure Information:
Title
Correlate pharmacogenetic analysis with veno-occlusive disease.
Description
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.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Participant characteristics.
Description
Age, sociodemographics, personal and cancer history.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Jolivot, MD
Phone
33-(0)2-41-35-58-08
Email
DeJolivot@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sybille Lazareff, CRA
Phone
33-(0)2-41-35-33-42
Email
SyLazareff@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Pellier, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesity Hostipal of Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Lutun, MD
Email
lutun.anne@chu-amiens.fr
Facility Name
University Hospital of Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
University of Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liana Carausu, MD
Email
liana.carausu@chu-brest.fr
Facility Name
University Hospital of Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Briandet, MD
Email
claire.briandet@chu-dijon.fr
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Sudour-Bonnange, MD
Email
h-sudour@o-lambret.fr
Facility Name
University Hospital of Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnauld Verschuur, MD
Email
Arnauld.VERSCHUUR@ap-hm.fr
Facility Name
University Hospital of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Thomas, MD
Email
caroline.thomas@chu-nantes.fr
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Benabida, MD
Email
Benadiba.j@chu-nice.fr
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauriane Lemelle, MD
Email
lauriane.lemelle@curie.fr
Facility Name
Hôpital Trousseau
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie Gandemer, MD
Email
virginie.gandemer@chu-rennes.fr
Facility Name
University Hospital of La Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Reguerre, MD
Email
yves.reguerre@chu-reunion.fr
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Blouin, MD
Email
p.blouin@chu-tours.fr
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Valteau-Couanet, MD
Email
dominique.valteau@gustaveroussy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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