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Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03231644
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Deanna Portero, Fibrous Dysplasia Foundation

Brief 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.


Condition or disease
Fibrous Dysplasia McCune Albright Syndrome Mazabraud Syndrome

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Fibrous Dysplasia, McCune-Albright Syndrome Patient Registry
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026


Group/Cohort
FD/MAS Patients
Patients with fibrous dysplasia and/or McCune-Albright syndrome and related disorders.



Primary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: Through study completion, an average of every 2 years ]
    FACIT-Treatment Satisfaction scale

  2. Perceived symptoms of pain [ Time Frame: Through study completion, an average of every 2 years ]
    Brief Pain Inventory

  3. Depression/anxiety [ Time Frame: Through study completion, an average of every 2 years ]
    Hospital Anxiety Depression Scale

  4. Stigma [ Time Frame: Through study completion, an average of every 2 years ]
    NeuroQol Pediatric and Adult Stigma short forms

  5. Health-related Quality of Life [ Time Frame: Through study completion, an average of every 2 years ]
    SF-36,PedsQL 4.0

  6. Financial health [ Time Frame: Through study completion, an average of every 2 years ]
    FACIT-Cost



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of all patients in these particular disease communities.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231644


Contacts
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Contact: Kiran Murty PI.Registry@fibrousdysplasia.org
Contact: Deanna Portero, PMP 917-513-2169 dportero@fibrousdysplasia.org

Locations
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United States, Michigan
FDMASRegistry.org Recruiting
Grandville, Michigan, United States, 49418
Contact: Tovah Burstein, MFA       registry@fibrousdysplasia.org   
Sponsors and Collaborators
Deanna Portero

Additional Information:

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Responsible Party: Deanna Portero, Executive Director, Fibrous Dysplasia Foundation
ClinicalTrials.gov Identifier: NCT03231644     History of Changes
Other Study ID Numbers: Pro00018980.
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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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

Keywords provided by Deanna Portero, Fibrous Dysplasia Foundation:
Fibrous Dysplasia
McCune-Albright Syndrome
Mazabrauds
FD/MAS

Additional relevant MeSH terms:
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Syndrome
Hyperplasia
Fibrous Dysplasia of Bone
Fibrous Dysplasia, Polyostotic
Disease
Pathologic Processes
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases