Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry

Fibrous Dysplasia Clinical Trial

Official title:

Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231644
• Other study ID #: Pro00018980.
• Status: Recruiting
• Start date: October 31, 2016
• Est. completion date: October 2026

Study information

• Verified date: February 2023
• Source: Fibrous Dysplasia Foundation
• Contact: Carmel Shemmesh-Rafalowsky
• Email: PI.Registry[@]fibrousdysplasia.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The FD/MAS Patient Registry is an IRB-approved research study that that invites the patients and families to help answer some of the biggest questions about FD/MAS by completing questionnaires about their lives with FD or MAS.

Have you enrolled in the FD/MAS Patient Registry yet? Are you up-to-date on your surveys? Take a trip to www.fdmasregistry.org today to learn more about the project, enroll, complete your surveys, or make sure you aren't due to provide more info!

The FD/MAS Patient Registry: Your story powers research.

Description:

The FD/MAS Patient Registry is an IRB approved research project that allows patients and families to share their experiences with fibrous dysplasia/McCune-Albright syndrome (FD/MAS) by completing a series of surveys.

The surveys were created in collaboration with patients, parents, clinicians and researchers, so that the data can be used to answer some of the most important questions about FD/MAS, including:

the way the disease develops over time (its "natural history"), the patient experience of the disease, and its impact on quality of life, how and when diagnoses are made, the scope of treatments in use, what surgical techniques work best, and for whom, what other medical interventions work best, and for whom, what social services and therapies are useful, the costs of care to patients and their families, issues that concern patients (such as the impact of pregnancy on FD, or children feeling different and facing stigma), and which research questions and support programs you think are important to fund.

Participation is free and convenient for people with FD/MAS and their legal guardians. You can join today at www.fdmasregistry.org.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria any one or more of the following:

• clinical diagnosis of fibrous dysplasia

• clinical diagnosis of McCune-Albright syndrome

• clinical diagnosis of Mazabraud's syndrome

Related Conditions & MeSH terms

• Fibrous Dysplasia
• Fibrous Dysplasia of Bone
• Hyperplasia
• Mazabraud Syndrome
• McCune Albright Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Tovah Burstein	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Tovah Burstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction	FACIT-Treatment Satisfaction scale	Through study completion, an average of every 2 years
Primary	Perceived symptoms of pain	Brief Pain Inventory	Through study completion, an average of every 2 years
Primary	Depression/anxiety	Hospital Anxiety Depression Scale	Through study completion, an average of every 2 years
Primary	Stigma	NeuroQol Pediatric and Adult Stigma short forms	Through study completion, an average of every 2 years
Primary	Health-related Quality of Life	SF-36,PedsQL 4.0	Through study completion, an average of every 2 years
Primary	Financial health	FACIT-Cost	Through study completion, an average of every 2 years