COLPAC (RaDiCo Cohort) (RaDiCo-COLPAC) (COLPAC)

February 10, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France

National Cohort About Epidemiology, Clinical and Genetic Heterogeneity of the "Low-Phospholipid-Associated Cholelithiasis" (LPAC) Syndrome

The goal of this observational study is to describe the various clinical, biological and radiological manifestations of LPAC syndrome, defined according to standard diagnostic criteria, or according to criteria extended to all symptomatic recurrent biliary lithiasis, and delineate the various possible evolutions.

Participants will be followed for 5 years and the inclusion sites will collect the necessary data at least once a year as part of routine patient care. A quality of life self-questionnaire will be completed by participants during these visits.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • Centre Hospitalier Intercommunal Aix-Pertuis
      • Annecy, France
        • Centre Hospitalier Annecy Genevois
      • Bobigny, France
        • Hopital Avicenne
      • Bordeaux, France
        • Hôpital Haut-Lévêque
      • Bry-sur-Marne, France
        • Hôpital Saint Camille
      • Caen, France
        • Hôpital Côte de Nacre
      • Clichy, France
        • Hopital Beaujon
      • Corbeil-Essonnes, France
        • Centre Hospitalier Sud Francilien
      • Créteil, France
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France
        • Hôpital François Mitterrand
      • Grenoble, France
        • Hopital Michallon
      • Lille, France
        • Hôpital Claude Huriez
      • Lyon, France
        • Hôpital de la Croix-Rousse
      • Orléans, France
        • Centre Hospitalier Régional d'Orléans
      • Paris, France
        • Hôpital Saint-Antoine
      • Poitiers, France
        • Hopital Jean Bernard
      • Reims, France
        • Hopital Robert Debre
      • Rouen, France
        • Hôpital Charles Nicolle
      • Strasbourg, France
        • Hôpital Civil
      • Toulouse, France
        • Hopital Rangueil
      • Villejuif, France
        • Hôpital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptive analysis of the clinical manifestations of LPAC syndrome like personal and family medical history of the disease, clinical features, medical complications, co-morbidities, death (age of onset and cause).
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Descriptive analysis of the biological manifestations of LPAC syndrome like hepatic biochemical tests and glucido-lipid tests
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Descriptive analysis of the radiological manifestations of LPAC syndrome like presence of stones or signs of intrahepatic, vesicular or main bile duct micro-lithiasis
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of diagnostic practices by a descriptive analysis of sequences of medical procedures used to diagnose LPAC syndrome.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Description of therapeutic practices by a descriptive analysis of the different curative and symptomatic treatments offered depending on the stage of the disease and the type of extra-hepatic complications.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Description of patient management practices.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Identification of new diagnostics by refining the collection of semiological fields of 1st degree relatives and including patients with recurrent symptomatic biliary lithiasis who do not fully meet the current diagnostic criteria for LPAC syndrome
Time Frame: Through study completion, an average of 5 years

The extension of the criteria will be proposed on the basis of the collection of all the semiological fields of patients diagnosed with an LPAC syndrome defined according to the usual or extended criteria and their 1st degree relatives.

The extended diagnostic criteria are :

  • Age of onset of the disease over 40 years of age
  • The presence of recurrent biliary lithiasis without radiological signs characteristic of LPAC syndrome (comet tails or intrahepatic lithiasis).

Patients with symptomatic gallstones who have only one of the 3 criteria for LPAC syndrome (onset before the age of 40, intrahepatic microlithiasis, recurrence after cholecystectomy).
Through study completion, an average of 5 years
Evaluation of response to medical and interventional treatments.
Time Frame: Through study completion, an average of 5 years

This evaluation criterion will be the search for correlation between response or non-response to medical and interventional treatments. This will be analysed by looking at the presence or absence of certain clinical, biochemical, molecular and radiological features of the disease such as :

  • No reduction in the frequency or intensity of painful attacks.
  • No reduction in the number of complications.
  • No improvement or normalisation of liver tests.
  • No regression or disappearance of radiological signs of intrahepatic lithiasis
  • No improvement in the criteria for assessing quality of life and impact on social life
Through study completion, an average of 5 years
Identification of prognostic factors (clinical, biochemical, radiological) associated with a poor therapeutic response by assessing the occurrence of events such as : - Fatal or non-fatal complications - Death due to hepatic or other causes
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Assessing the impact of LPAC syndrome on quality of life.
Time Frame: Through study completion, an average of 5 years
Impact of disease on quality of life will be evaluated through scores of quality of life questionnaires (SF-36)
Through study completion, an average of 5 years
Evaluation of the proportion of patients referred to LPAC within the population referred to the hepatology and/or digestive surgery departments for biliary lithiasis during the same study period
Time Frame: Through study completion, an average of 5 years

The relative prevalence of LPAC syndrome (number of cases of LPAC syndrome compared with the number of cases of gallbladder disease) will be measured from 1 March 2016 to 28 February 2017, based on cases recorded in the centres participating in the study.

The relative incidence (number of new cases of LPAC syndrome compared with the number of new cases of gallstones) will be measured over the same period, in the same centres.

The total number of patients seen in hospital or in consultation during the same period for gallstones will be collected in each participating hospital using the pmsi code.
Through study completion, an average of 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deepening the study of the genotype/phenotype correlations of the ABCB4 gene with assessment of the number of painful attacks and complications, presence of radiological signs, measurement of biological assays, good or poor response to treatment
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Documenting the genetic transmission profile and heritability (penetrance) of the LPAC syndrome by analysing the phenotypes and genotypes of patients and their 1st degree relatives (whether or not they have declared illness).
Time Frame: Through study completion, an average of 5 years

The evaluation criteria will be :

  • the collection of common genetic mutations in the patient and 1st degree relatives (carried out as part of the diagnostic study of the index case)
  • the search for common phenotypes in the patient and 1st degree relatives (carried out as part of the diagnostic study of the index case)
Through study completion, an average of 5 years
Search for new susceptibility genes in patients without gene alterations of ABCB4
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years
Search for modulating genes in mutated and non-mutated ABCB4 patients.
Time Frame: Through study completion, an average of 5 years
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Christophe CORPECHOT, INSERM UMR_S938

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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