- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798950
Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study
February 7, 2023 updated by: Centre Hospitalier Intercommunal Creteil
The study hypothesis is that dilations of idiopathic bronchi are particularly common in French Polynesia, and that there are arguments in favour of an underlying genetic factor.
The study will retrieve retrospective data in the history of bronchial dilation, patients' personal and family history, microbiological and scannographic data, and the latest cardio respiratory checkup.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
500 patients with bronchial dilatation over the study period: Jan 1, 2010 to Dec 31, 2020
Description
Inclusion Criteria:
- Polynesian patient
- Patient with bronchial dilation followed by Centre hospitalier de Polynesie Francaise or patient with bonchial dilation no longer consulting in the hospital over the study period Jan 1, 2010 to Dec 31, 2020
Exclusion Criteria:
- Expressed refusal to participate in the study for patients undergoing follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe the detailed phenotype of bronchi dilation in the Polynesian population
Time Frame: Day 1
|
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Highlighting indirect arguments for a genetic cause
Time Frame: Day 1
|
Age of onset of symptoms, frequency of so-called "idiopathic" bronchi dilatation, frequency of inbreeding, familial history
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2023
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
June 1, 2024
Study Registration Dates
First Submitted
March 11, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (ACTUAL)
March 16, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Congenital Abnormalities
- Bronchial Diseases
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Abnormalities, Multiple
- Ciliopathies
- Respiratory System Abnormalities
- Dextrocardia
- Situs Inversus
- Ciliary Motility Disorders
- Bronchiectasis
- Kartagener Syndrome
Other Study ID Numbers
- POLYDEB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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