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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04168788
• Collaborator: (none)
• Enrollment: 150
• Locations: 16
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Veno-Occlusive Disease; Nephroblastoma; Acute Lymphoblastic Leukemia	Other: Blood test for genetic analysis	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Nephrobalstoma or ALL Pateints treated for a nephrobalstoma or ALL in childhood or adolescence	Other: Blood test for genetic analysis; Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.

Outcome Measures

Primary Outcome Measures

1. Correlate pharmacogenetic analysis with veno-occlusive disease. [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 Outcome Measures

1. Participant characteristics. [One day]

   Age, sociodemographics, personal and cancer history.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univesity Hostipal of Amiens	Amiens		France	80054
2	University Hospital of Bordeaux	Bordeaux		France	33000
3	University of Brest	Brest		France	29609
4	University Hospital of Dijon	Dijon		France	21079
5	Centre Oscar Lambret	Lille		France	59020
6	University Hospital of Limoges	Limoges		France	87042
7	Hôpital La Timone	Marseille		France	13385
8	University Hospital of Nantes	Nantes		France	44093
9	University Hospital of Nice	Nice		France	06200
10	Institut Curie	Paris		France	75005
11	Hôpital Trousseau	Paris		France	75571
12	University Hospital of Poitiers	Poitiers		France	86000
13	University Hospital of Rennes	Rennes		France	35203
14	University Hospital of La Réunion	Saint-Denis		France	97400
15	University Hospital of Tours	Tours		France	37044
16	Gustave Roussy	Villejuif		France	94805

Sponsors and Collaborators

• University Hospital, Angers

Investigators

• Principal Investigator: Isabelle Pellier, MD, University Hospital, Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT04168788
• Other Study ID Numbers: 49RC19_0197
• First Posted: Nov 19, 2019
• Last Update Posted: Nov 19, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Angers: Pharmacogenetics
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Wilms Tumor; Hepatic Veno-Occlusive Disease

Study Results

No Results Posted as of Nov 19, 2019