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Scientists launch Largest-Ever study of mysterious gallstone disease

NCT ID NCT05961826

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study follows 650 children and adults with LPAC syndrome, a rare condition that causes repeated gallstones even after gallbladder removal. Researchers will collect medical history, lab results, and imaging data over 5 years to describe the disease's full range of symptoms and outcomes. Participants complete a quality-of-life questionnaire yearly. No new treatments are tested; the goal is to better understand the disease.

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.

Participants

About 650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Jun 2028

An estimate. End dates often move.

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.

Who is studied

This study concerns all prevalent and incident patients who meet the standard or extended diagnostic criteria for LPAC syndrome, whatever the existing genetic data concerning ABCB4, or who have been referred as having a mutation in the ABCB4 gene in a clinical context of biliary lithiasis.

Ages

13 years and older

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 or adults meeting the standard\* or extended\*\* diagnostic criteria for LPAC syndrome: 1. First symptoms before the age of 40 years 2. Radiological images compatible with the existence of intrahepatic lithiasis 3. Recurrence of symptoms after cholecystectomy (\*) standard criteria: symptomatic biliary lithiasis with at least 2 out of 3 criteria (\*\*) extended criteria: symptomatic biliary lithiasis with 1 out of 3 criteria Exclusion Criteria: * Patients who have undergone liver transplantation

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Conditions

The condition(s) this trial relates to.

gallbladder disease 1

As listed by the trial registrant

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

Low phospholipid associated cholelithiasis

Contacts and locations

Locations

  • Centre Hospitalier Annecy Genevois

    Annecy, France

  • Centre Hospitalier Intercommunal Aix-Pertuis

    Aix-en-Provence, France

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, France

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, France

  • Centre hospitalier régional d'Orléans

    Orléans, France

  • Hôpital Avicenne

    Bobigny, France

  • Hôpital Beaujon

    Clichy, France

  • Hôpital Charles Nicolle

    Rouen, France

  • Hôpital Civil

    Strasbourg, France

  • Hôpital Claude Huriez

    Lille, France

  • Hôpital Côte de Nacre

    Caen, France

  • Hôpital François Mitterrand

    Dijon, France

  • Hôpital Haut-Lévêque

    Bordeaux, France

  • Hôpital Jean Bernard

    Poitiers, France

  • Hôpital Michallon

    Grenoble, France

  • Hôpital Paul Brousse

    Villejuif, France

  • Hôpital Rangueil

    Toulouse, France

  • Hôpital Robert Debré

    Reims, France

  • Hôpital Saint Camille

    Bry-sur-Marne, France

  • Hôpital Saint-Antoine

    Paris, France

  • Hôpital de la Croix-Rousse

    Lyon, France