Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome

NCT ID: NCT03040115

Last Updated: 2024-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-08-31

Brief Summary

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The aim of this study is to conduct survey-based assessments for the safety of air travel in patients with Birt-Hogg-Dube syndrome (BHD). The study will enroll patients through the clinic network at Rare Lung Disease Consortium (RLDC) and through the BHD foundation website. Patients will have access to the questionnaire via REDCap (an online data management system) and each patient will be provided with a link to complete the survey. The investigators plan on enrolling approximately 100 patients with BHD for the purpose of this study. Secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.

Detailed Description

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Conditions

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Birt-Hogg-Dube Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Non-Interventional Study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult, age 18 or older
* English literate
* Signed, dated informed consent; either given electronically or via paper form
* Diagnosis of BHD confirmed by either a) the presence of fibrofolliculomas/trichodiscomas on skin biopsy, or b) the presence of pathogenic FLCN mutations.

Exclusion Criteria

* Inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rare Diseases Clinical Research Network

NETWORK

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Nishant Gupta, MD, MS

Adjunct Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nishant Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U54HL127672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RLDC5714A

Identifier Type: -

Identifier Source: org_study_id

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