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Can genes predict liver damage from childhood cancer drugs?

NCT ID NCT04168788

Knowledge-focused Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study investigates whether certain genetic differences make children with nephroblastoma (kidney cancer) or acute lymphoblastic leukemia (blood cancer) more likely to develop a serious liver condition called hepatic veno-occlusive disease (VOD) during chemotherapy. Researchers will analyze blood samples from 85 children treated in France between 2000 and 2018 to look for genetic markers linked to this toxicity. The goal is to better understand why some children experience this severe side effect, which can interrupt treatment and be life-threatening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If genetic markers are found, doctors could identify children at higher risk for liver damage and adjust their cancer treatment to avoid it.
What could go wrong
This is an observational study that looks back at past cases, so it cannot prove cause and effect. The results may not apply to all children or treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

85 people

The number who actually took part.

Started

Jan 2020

Finished

Jul 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia hepatic veno-occlusive disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Wilms tumor Wilms tumor 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia Hepatic veno-occlusive disease Nephroblastoma

Contacts and locations

Locations

  • Centre Oscar Lambret

    Lille, 59020, France

  • Hôpital La Timone

    Marseille, 13385, France

  • Hôpital Trousseau

    Paris, 75571, France

  • University Hospital of Bordeaux

    Bordeaux, 33000, France

  • University Hospital of La Réunion

    Saint-Denis, 97400, France

  • University Hospital of Nice

    Nice, 06200, France

  • University Hospital of Poitiers

    Poitiers, 86000, France

  • University Hospital of Rennes

    Rennes, 35203, France

  • University Hospital of Tours

    Tours, 37044, France

  • University of Brest

    Brest, 29609, France

  • Univesity Hostipal of Amiens

    Amiens, 80054, France

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