Hepatic Veno-Occlusive DiseaseMVONCT04168788
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL
A study testing Blood test for genetic analysis in people with Hepatic Veno-Occlusive Disease and Nephroblastoma, run by University Hospital, Angers at 11 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Hepatic Veno-Occlusive Disease, Nephroblastoma, Acute Lymphoblastic Leukemia
- What is being tested?
- Blood test for genetic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jan 2020to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Univesity Hostipal of Amiens
Amiens, 80054
University Hospital of Bordeaux
Bordeaux, 33000
University of Brest
Brest, 29609
Centre Oscar Lambret
Lille, 59020
Hôpital La Timone
Marseille, 13385
University Hospital of Nice
Nice, 06200
Hôpital Trousseau
Paris, 75571
University Hospital of Poitiers
Poitiers, 86000
University Hospital of Rennes
Rennes, 35203
University Hospital of La Réunion
Saint-Denis, 97400
University Hospital of Tours
Tours, 37044
About this study
Official title: Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
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.
Read the 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.
- Being tested
- Blood test for genetic analysis
- Keywords
- Pharmacogenetics
- Medical subject headings
- Hepatic Veno-Occlusive Disease, Wilms Tumor, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test for genetic analysisOther
Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.
| Study group | Role | What they receive |
|---|---|---|
| Nephrobalstoma or ALL | Other | Pateints treated for a nephrobalstoma or ALL in childhood or adolescence Receives: Other: Blood test for genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (1)
Participant characteristics.
Age, sociodemographics, personal and cancer history.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jan 2020
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Veno-Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Pellier, MD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168788
- Sponsor's protocol ID
- 49RC19_0197
- Acronym
- MVO
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04168788
- Acronym / sponsor ID
- MVO / 49RC19_0197
- Keywords
- Pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nephrobalstoma or ALL | Other | Other: Blood test for genetic analysisPateints treated for a nephrobalstoma or ALL in childhood or adolescence |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test for genetic analysisDrawing blood to realize a genetic analysis for susceptibility to hepatic VOD. | Other | Nephrobalstoma or ALL |
Primary outcome
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.
1 secondary outcome
Participant characteristics.
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Pellier, MD principal investigator
University Hospital, Angers
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test for genetic analysis in people with Hepatic Veno-Occlusive Disease and Nephroblastoma, run by University Hospital, Angers at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate pharmacogenetic analysis with veno-occlusive disease. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.