Fibrous Dysplasia of BoneTIM-DYSNCT06177327
Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone/McCune Albright Syndrome
An observational study of Fibrous Dysplasia of Bone, run by Hospices Civils de Lyon at 16 sites in France.
Trial summary
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 … Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fibrous Dysplasia of Bone
- What is being tested?
- Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions.
- How many people
- 545 participants
- Where
- 16 sitesFrance
- Study dates
- 19 Jan 2024to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- -Opposition to data collection
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites, 16 recruiting
- Not yet recruiting
CHU Angers
Angers, 49100
Béatrice BOUVARD, MD, +33 (0)2 41 35 36 37, BeBouvard@chu-angers.fr
- Not yet recruiting
Groupe Hospitalier Pellegrin - Chu
Bordeaux, 33076
Nadia MEHSEN-CETRE
+33 (0)5 56 79 56 79 nadia.mehsen@chu-bordeaux.fr
- Not yet recruiting
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29609
Thierry MARHADOUR, MD, +33 (0)2 98 34 72 67, thierry.marhadour@chu-brest.fr
- Not yet recruiting
Chu de Caen Normandie
Caen, 14000
Christian Marcelli, MD,PhD, + 33 (0)2 31 06 47 55, marcelli-c@chu-caen.fr
- Not yet recruiting
Chu de Clermont-Ferrand
Clermont-Ferrand, 63000
Sandrine MALOCHET, MD, +33 (0)5-61-77-69-84, smalochet@chu-clermontferrand.fr
- Not yet recruiting
Chu de Lille
Lille
Bernard Cortet, MD,PhD, + 33 (0)3 20 44 40 83, bernard.cortet@chu-lille.fr
- Not yet recruiting
Service Rhumatologie, pavillon F Hopital E. Herriot
Lyon, 69437
Roland Chapurlat, MD,PhD, + 33 (0)472117482, roland.chapurlat@chu-lyon.fr
- Not yet recruiting
Assistance Publique - Hopitaux de Marseille (Ap-Hm
Marseille, 13009
Pierre LAFFORGUE, +33 (0)4 91 74 42 03, Pierre.LAFFORGUE@ap-hm.fr
- Not yet recruiting
Chu de Montpellier
Montpellier, 34295
Cyril AMOUROUX, + 33 (0)4 67 33 65 06, cyril-amouroux@chu-montpellier.fr
- Not yet recruiting
CHU de Nice
Nice, 06200
Veronique BREUIL, MD, PhD, +33 (0)4 93 86 68 39, breuil.v@chu-nice.fr
- Not yet recruiting
Assistance Publique - Hopitaux de Paris (Ap-Hp)
Paris, 75010
Thomas FUNCK-BRENTANO, MD, PhD, + 33 (0)1 49 95 63 58, thomas.funck-brentano@aphp.fr
- Not yet recruiting
CHU de Poitiers
Poitiers, 86000
Françoise DEBIAIS, MD,PhD, +33 (0)5 49 44 44 65, francoise.debiais@chu-poitiers.fr
- Not yet recruiting
Chu de Rennes
Rennes, 35203
Pascal GUGGENBUHL, Md, PhD, +33 (0)2 99 26 71 40, pascal.guggenbuhl@chu-rennes.fr
- Recruiting
Chu de Saint-Etienne
Saint-Etienne, 42055
Adamah AMOUZOUGAN, MD, +33 (0)4 77 12 76 49, adamah.amouzougan@chu-st-etienne.fr
- Not yet recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67091
Rose-Marie JAVIER, MD, +33 (0)3 88 12 79 64, rose-marie.javier@chru-strasbourg.fr
- Not yet recruiting
Chu de Toulouse
Toulouse, 31300
Guillaume COUTURE, MD, +33 (0)5-61-77-69-84, couture.g@chu-toulouse.fr
About this study
Official title: 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.
- Conditions
- Fibrous Dysplasia of Bone
- Being tested
- Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions.
- Keywords
- Fibrous dysplasia of bone, McCune Albright syndrome, pancreatic neoplasms, IPMN
- Medical subject headings
- Fibrous Dysplasia of Bone, Fibrous Dysplasia, Polyostotic, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions.Other
Data collection from hepato-bilio-pancreatic Magnetic Resonance Imaging realized during the follow up of patients with Fibrous dysplasia of bone /McCune Albright syndrome
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe hepato-bilio-pancreatic abnormalities in FD/MAS and estimate the prevalence of IPMN.
Hepato-bilio-pancreatic abnormalities (size, number, complications) will be described based on hepato-bilio-pancreatic MRI.
Measured: hepato-bilio-pancreatic MRI performed from January 2002 until December 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start19 Jan 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrous Dysplasia of BoneStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177327
- Sponsor's protocol ID
- 23-5288
- Acronym
- TIM-DYS
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Epidemiology of Hepato-pancreato-biliary Abnormalities in Fibrous Dysplasia of Bone /McCune Albright Syndrome: the TIM-DYS Study
- ClinicalTrials.gov ID
- NCT06177327
- Acronym / sponsor ID
- TIM-DYS / 23-5288
- Conditions
- Fibrous Dysplasia of Bone
- Keywords
- Fibrous dysplasia of bone, McCune Albright syndrome, pancreatic neoplasms, IPMN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 545 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with polyostotic fibrous dysplasia McCune Albright syndrome | – | Other: Screening for hepato-bilio-pancreatic abnormalities in Fibrous dysplasia of bone /McCune Albright syndrome , description and characterization of the lesions.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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -Opposition to data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Adults with polyostotic fibrous dysplasia McCune Albright syndrome |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrous Dysplasia of Bone, run by Hospices Civils de Lyon at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roland Chapurlat, MD, PhD (+ 33 (0)4 72 11 74 82, roland.chapurlat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.