Birt-Hogg-Dube SyndromeNCT03040115
Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome
An observational study of Birt-Hogg-Dube Syndrome, run by University of Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Birt-Hogg-Dube Syndrome
- What is being tested?
- Non-Interventional Study
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a confirmed diagnosis of Birt-Hogg-Dube syndrome are eligible to participate in this study.
Who may be able to join
- 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.
Who cannot join
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Birt-Hogg-Dube Syndrome
- Being tested
- Non-Interventional Study
- Medical subject headings
- Birt-Hogg-Dube Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel
The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with Birt-Hogg-Dube syndrome. The incidence of air travel related pneumothorax will be calculated by dividing the number of pneumothoraces to the total number of flights undertaken by the entire cohort.
Measured: During air travel or within 24 hours following air travel
Secondary outcomes (2)
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience a Spontaneous Pneumothorax
The investigators will catalogue the number of spontaneous pneumothoraces experienced by patients with Birt-Hogg-Dube syndrome.
Measured: 3 years
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience Recurrent Pneumothorax Following Pleurodesis
The investigators will measure the incidence of ipsilateral pneumothorax following pleurodesis in order to determine the efficacy (as measured by the rate of pneumothorax recurrence following pleurodesis).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startAug 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Birt-Hogg-Dube SyndromeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Cross-sectional
- Enrolment
- 104 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Rare Diseases Clinical Research Network, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nishant Gupta, MD, MS, University of Cincinnati
- Investigators
- Nishant Gupta, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040115
- Sponsor's protocol ID
- RLDC5714A
- Other IDs
- U54HL127672
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2017
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety of Air Travel in Patients With Birt-Hogg-Dube Syndrome
- ClinicalTrials.gov ID
- NCT03040115
- Acronym / sponsor ID
- RLDC5714A
- Conditions
- Birt-Hogg-Dube Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Rare Diseases Clinical Research Network, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2015
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a confirmed diagnosis of Birt-Hogg-Dube syndrome are eligible to participate in this study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to give informed consent
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 |
|---|---|---|
| Non-Interventional Study | Other | – |
Primary outcome
Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel
Time frame: During air travel or within 24 hours following air travel
The investigators will measure the number of pneumothoraces that occur either during air travel, or within 24 hours of air travel among patients with Birt-Hogg-Dube syndrome. The incidence of air travel related pneumothorax will be calculated by dividing the number of pneumothoraces to the total number of flights undertaken by the entire cohort.
2 secondary outcomes
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience a Spontaneous Pneumothorax
Time frame: 3 years
Number of Patients With Birt-Hogg-Dube Syndrome Who Experience Recurrent Pneumothorax Following Pleurodesis
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Birt-Hogg-Dube Syndrome
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingObservational study
Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
Quality of Life, Ichthyosis
Enrolling by invitationObservational study
Reproductive Options in Inherited Skin Diseases
Ichthyosis, Palmoplantar Keratoses
RecruitingObservational study
MyVHL: Patient Natural History Study
Von Hippel-Lindau Disease, Hereditary Leiomyomatosis and Renal Cell Cancer
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.
Nishant Gupta, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birt-Hogg-Dube Syndrome, run by University of Cincinnati at 1 site in United States.
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: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Birt-Hogg-Dube Syndrome Who Experienced Spontaneous Pneumothorax During or Within 24 Hours Following Air Travel (time frame: During air travel or within 24 hours following air travel). 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 31 Jan 2024.