DCP (RaDiCo Cohort) (RaDiCo-DCP)

Status Recruiting

Clinical Trial Summary

Primary Ciliary Dyskinesias (PCD) are rare, autosomal recessive respiratory diseases, due to a defect in mucociliary clearance linked to abnormalities in the structure and/or function of the cilia. The variety of ciliary abnormalities identified reflects the genetic heterogeneity of PCDs. The thirty or so genes currently implicated explain the pathology in about half of the patients. PCDs are characterized by recurrent infections of the upper (rhinosinusitis) and lower (bronchitis) airways, beginning in early childhood and progressing respectively to nasal polyposis and bronchial dilatation. In half of the cases, there is a lateralization defect of the organs (situs inversus) corresponding to Kartagener's syndrome. There is more frequent infertility in men (immobility of spermatozoa) than in women (miscarriages and tubal pregnancies). About a third of patients progress to respiratory failure. The identification of predictive factors of severity, specific to PCDs, would improve patient care. It is also important to assess the quality of life of patients with PCD, particularly at the ENT level. Data from prevalent patients are currently integrated into three separate and complementary databases: the "e-RespiRare" database, the "DCP Cils" database and the "DCP genes" database. The first step is therefore to constitute the RaDiCo-DCP database which will include data from prevalent and incident patients whose diagnosis of PCD is certain. The cohort aims to improve the routine care of PCD patients, in particular by highlighting predictive factors of severity, allowing early and personalized care, to assess the social impact (quality of life) and medical conditions of ENT impairment, as well as adult infertility, to finely characterize the ciliary phenotype. The study also aims to search for new DCP genes and to allow genotype/phenotype correlation studies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05951478
Study type	Observational
Source	Institut National de la Santé Et de la Recherche Médicale, France
Contact	Bernard MAITRE
Phone	+33 1 57 02 20 82
Email	bernard.maitre@chicreteil.fr
Status	Recruiting
Phase
Start date	May 2, 2017
Completion date	December 31, 2028

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT05889013` - Utility of PCD Diagnostics to Improve Clinical Care
Recruiting	`NCT01246258` - Otolith Function in Patients With Primary Ciliary Dyskinesia	N/A
Completed	`NCT04858191` - Utilizing Hyperpolarized 129Xe Magnetic Resonance Imaging in Children With Primary Ciliary Dyskinesia
Completed	`NCT05712798` - Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals
Completed	`NCT03370029` - Respiratory Muscle Strength, Exercise Capacity and Physical Activity Levels in Children Primary Ciliary Dyskinesia
Completed	`NCT00368446` - Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
Recruiting	`NCT05374720` - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy	N/A
Completed	`NCT05816876` - Muscle Function, Exercise Capacity and Physical Activity Level in Primary Ciliary Dyskinesia and Kartagener Syndrome
Recruiting	`NCT04717115` - Genotype/Phenotype Correlation With Focus on Lung Function in Primary Ciliary Dyskinesia (PCD)
Recruiting	`NCT03279965` - MRI in Cystic Fibrosis and Primary Ciliary Dyskinesia	N/A
Recruiting	`NCT03320382` - Multiple Breath Washout, a Clinimetric Dataset
Recruiting	`NCT04602481` - COVID-19 in People With Primary Ciliary Dyskinesia
Not yet recruiting	`NCT02704455` - Registry Study on Primary Ciliary Dyskinesia in Chinese Children	N/A
Completed	`NCT00323167` - Rare Genetic Disorders of the Breathing Airways
Recruiting	`NCT05932316` - Evaluating Bronchodilator Response in Patients With Bronchiectasis	N/A
Completed	`NCT03832491` - Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia	N/A
Completed	`NCT06028607` - Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia	N/A
Recruiting	`NCT05685186` - A Longitudinal, Observational Study of Primary Ciliary Dyskinesia in Adults
Recruiting	`NCT05161858` - Longitudinal Characterization of Respiratory Tract Exacerbations and Treatment Responses in Primary Ciliary Dyskinesia
Recruiting	`NCT04611516` - The Ear-Nose-Throat (ENT) Prospective International Cohort of PCD Patients (EPIC-PCD)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

DCP (RaDiCo Cohort) (RaDiCo-DCP) — DCP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms