Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-04 @ 4:30 PM
Study NCT ID:
NCT04798950
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007619', 'term': 'Kartagener Syndrome'}], 'ancestors': [{'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002925', 'term': 'Ciliary Motility Disorders'}, {'id': 'D015619', 'term': 'Respiratory System Abnormalities'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003914', 'term': 'Dextrocardia'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012857', 'term': 'Situs Inversus'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the detailed phenotype of bronchi dilation in the Polynesian population', 'timeFrame': 'Day 1', 'description': '* Clinical criteria: age of onset, personal or family history, smoking Changes in respiratory function\n* Infectious complications: types of bronchial colonization (bacterial, mycobacterial and mycological)\n* Scantographic aspect: Appearance of bronchectasis: cylindrical, varicose orcious, cystic Distributions: LSD, LM, LID, LSG, LIG'}], 'secondaryOutcomes': [{'measure': 'Highlighting indirect arguments for a genetic cause', 'timeFrame': 'Day 1', 'description': 'Age of onset of symptoms, frequency of so-called "idiopathic" bronchi dilatation, frequency of inbreeding, familial history'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchi dilatation'], 'conditions': ['Polynesian Bronchiectasis']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '500 patients with bronchial dilatation over the study period: Jan 1, 2010 to Dec 31, 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polynesian patient\n* 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\n\nExclusion Criteria:\n\n* Expressed refusal to participate in the study for patients undergoing follow-up'}, 'identificationModule': {'nctId': 'NCT04798950', 'briefTitle': 'Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study', 'orgStudyIdInfo': {'id': 'POLYDEB'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benoit Douvry, MD', 'role': 'CONTACT', 'email': 'Benoit.Douvry@chicreteil.fr', 'phone': '01 45 17 57 28'}, {'name': 'Eric PARRAT, MD', 'role': 'CONTACT', 'email': 'eric.parrat@cht.pf', 'phone': '00 689 87707790'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}