Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone/McCune Albright Syndrome (TIM-DYS)

February 27, 2024 updated by: Hospices Civils de Lyon

Screening and Epidemiology of Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone /McCune Albright Syndrome: the TIM-DYS Study

Fibrous dysplasia of bone /McCune Albright syndrome (FD/MAS) is a rare bone disease caused by somatic mutations in GNAS gene. This GNAS mutation predisposes to cancers, including breast cancer, thyroid cancer, chondrosarcoma and osteosarcoma, as well as biliary tract anomalies, liver-tumors or pancreatic tumors - IPMNs. Intraductal papillary and mucinous neoplasms of the pancreas (IPMN) are cystic intraepithelial ductal lesions developed at the expense of pancreatic ducts. They are pre-cancerous lesions, requiring monitoring and, in case of progression or malignant degeneration, surgical resection. Pancreatic MRI screening of patients with polyostotic FD and MAS is recommended.

The aim of this study is to investigate the epidemiology and characteristics of these hepato-pancreato-biliary abnormalities (prevalence, age of onset, degeneration), based on magnetic resonance imaging (MRI) realized during the follow-up of patients with FD/MAS treated in a French FD expert center.

A better understanding of these IPMNs and other digestive abnormalities will enable clinicians to improve the management and monitoring in this high-risk population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

545

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49100
        • Not yet recruiting
        • Chu Angers
        • Contact:
      • Bordeaux, France, 33076
        • Not yet recruiting
        • Groupe Hospitalier Pellegrin - CHU
        • Contact:
          • Nadia MEHSEN-CETRE
        • Contact:
          • +33 (0)5 56 79 56 79 nadia.mehsen@chu-bordeaux.fr
      • Brest, France, 29609
        • Not yet recruiting
        • CHU de Brest - Hôpital de la Cavale Blanche
        • Contact:
      • Caen, France, 14000
        • Not yet recruiting
        • CHU de Caen Normandie
        • Contact:
      • Clermont-Ferrand, France, 63000
      • Lille, France
        • Not yet recruiting
        • CHU de LILLE
        • Contact:
      • Lyon, France, 69437
        • Not yet recruiting
        • Service Rhumatologie, pavillon F Hopital E. Herriot
        • Contact:
      • Marseille, France, 13009
        • Not yet recruiting
        • Assistance Publique - Hopitaux de Marseille (Ap-Hm
        • Contact:
      • Montpellier, France, 34295
      • Nice, France, 06200
        • Not yet recruiting
        • CHU de Nice
        • Contact:
      • Paris, France, 75010
        • Not yet recruiting
        • Assistance Publique - Hôpitaux de Paris (AP-HP)
        • Contact:
      • Poitiers, France, 86000
      • Rennes, France, 35203
      • Saint-Étienne, France, 42055
      • Strasbourg, France, 67091
      • Toulouse, France, 31300
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Adults ≥18 years with polyostotic FD/MAS
  • Followed up in the national FD reference center (Lyon) or in a FD French expert center: Angers, Bordeaux, Brest, Caen, Clermont-Ferrand, Lille, Marseille, Montpellier, Nice, Paris, Poitiers, Rennes, Saint-Etienne, Strasbourg.
  • who had an hepato-bilio-pancreatic MRI during their follow-up, since January 2002
  • No objection to data collection

Exclusion Criteria:

-Opposition to data collection

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with polyostotic fibrous dysplasia McCune Albright syndrome
A retrospective data collection and statistical analyses will be performed. Adults with polyostotic fibrous dysplasia McCune Albright syndrome, who underwent an hepato-bilio-pancreatic MRI since January 2002, during their follow-up
Other: Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions.
Data collection from hepato-bilio-pancreatic Magnetic Resonance Imaging realized during the follow up of patients with Fibrous dysplasia of bone /McCune Albright syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe hepato-bilio-pancreatic abnormalities in FD/MAS and estimate the prevalence of IPMN.
Time Frame: hepato-bilio-pancreatic MRI performed from January 2002 until December 2024.
Hepato-bilio-pancreatic abnormalities (size, number, complications) will be described based on hepato-bilio-pancreatic MRI.
hepato-bilio-pancreatic MRI performed from January 2002 until December 2024.

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

January 19, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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