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NCT06177327: TIM-DYS

Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone/McCune Albright Syndrome

Status unknown Last updated 29 February 2024
What this trial tests

trial testing Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions. in Fibrous Dysplasia of Bone in 545 participants. Status unknown.

Timeline
19 January 2024
Primary endpoint
30 November 2024
12 December 2025

Quick facts

Lead sponsorHospices Civils de Lyon
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment545
Start date19 January 2024
Primary completion30 November 2024
Estimated completion12 December 2025
Sites16 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 100, any sex, with Fibrous Dysplasia of Bone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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