Spontaneous Pneumothorax Clinical Trial
Official title:
Prevalence of Birt-Hogg-Dubé Syndrome Among Patients With (Hereditary) Spontaneous Pneumothorax
To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate hospital are to be included. Patients will receive a questionnaire. When given consent, the investigators will invite them for a one-time visit to the out-patient clinic. Patients will be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a pulmonary CT scan for evaluation of presence of lung cysts.
Based on the results of the pilot study in VUmc *Free University Medical Center), in which 3
out of 40 tested patients had a pathological FLCN mutation, the investigators decided to
extend the study to a second center; Rijnstate Hospital Arnhem. In this hospital a
retrospective search was performed; patients who were treated for primary spontaneous
pneumothorax were included. In the dossiers the investigators searched for medical history,
pneumothorax side and recurrence, diagnostic imaging, treatment, co-morbidity, complications
of treatment, skin abnormalities, kidney disease, smoking behavior, medication, and familial
incidence of pneumothorax and other diseases. Patients will receive a letter with
explanation of the research and a questionnaire in which the investigators ask them their
about the medical status, co-morbidity, pneumothorax (number and side), smoking behavior,
use of drugs, familial incidence of pneumothorax and other diseases.
The population will be formed out of patients who have returned the fully filled in
questionnaire and who have given permission to receive information for further research.
This further information will consist of an information letter on BHD syndrome and a consent
form for a one-time visit to the out-patient clinic of Rijnstate hospital. Investigators
expect that about 200 patients will return the fully filled in questionnaire and give their
consent for further research. In a one-time visit in out-patient clinic, there will be given
personal information on BHD syndrome and there will be performed physical examination for
finding fibrofolliculomas. A pulmonary CT scan for evaluation of presence of lung cysts will
be performed. Two samples of venous blood will be collected to access information on DNA
diagnostics for pathogenic FLCN mutations. These are associated with the BHD syndrome. This
last diagnostic testing will be performed in VUmc (Vrije Universiteit medisch centrum or
Free University Medical Centre).
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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