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Impaired Secretory IgA and Mucosal Immunity in Cystic Fibrosis (Forton2015)

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ClinicalTrials.gov Identifier: NCT02308267
Recruitment Status : Unknown
Verified February 2016 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
This project entitled "Impaired secretory IgA and mucosal immunity in cystic fibrosis" is a research program which aims to determine, owing to national (KULeuven) and international (Descartes university Paris, university of Torino) collaborations for expertise and access to human material, whether a defect exists for the production of IgA antibodies in the lung from patients with this serious genetic disease. These antibodies line and protect normally the airways, and are secreted through a specific epithelial receptor called pIgR (polymeric immunoglobulin receptor); its expression and regulation will be studied in lung tissue and in cell cultures of the lung epithelium from these patients. The link between the putative IgA defect and chronic bacterial infection with Pseudomonas aeruginosa, which often complicates the evolution of the disease, will also be evaluated ex vivo and in vivo, in an animal model of lung infection.

Condition or disease Intervention/treatment
Cystic Fibrosis Other: Lung explants Other: Sputum, nasal fluid and serum Procedure: Bronchoscopy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impaired Secretory IgA and Mucosal Immunity in Cystic Fibrosis: Contribution to Lung Pathology and Impaired Defence Against Bacterial Infection
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cystic fibrosis
Cystic fibrosis patients More than 18 years old DF508/DF508 mutation colonized or not with Pseudomonas aeruginosa
Other: Lung explants
Lung explants from end-stage CF, which were obtained for a reason independent from the study in the Paris (Prof Burgel) and Leuven (Prof Dupont) centres will be analysed for pIgR and IgA expression as well as for Pseudomonas aeruginosa colonization. Some lung explants from control patients will also be obtained from the Leuven centre.

Other: Sputum, nasal fluid and serum
Sputum, nasal (fluid) and serum samples from CF patients and controls patients will be collected (Leuven, Paris, Torino, Verona and Saint-Luc Brussels) for S-IgA and microbiological assays. Spontaneous sputum will be collected, while nasal fluid will be sampled through nasal lavage. Control subjects will consist of COPD patients and healthy subjects (smokers or not).

Procedure: Bronchoscopy
Endobronchial biopsies (EBB) and broncho-alveolar lavage (BAL) will be sampled at the KULeuven centre (Prof Dupont) in some CF patients (homozygous for the DF508 mutation) and colonized or not with Pseudomonas aeruginosa and who must have a general anaesthesia for a reason independent from the study. In these patients, a bronchial endoscopy will be performed during narcosis to take EBB (n=8) and BAL (2x50mL). If possible, nasal and rectal biopsies will also be performed in some patients. Samples will be assessed for pIgR and IgA expression and for primary broncho-epithelial cultures (carried out at the UCL centre, Pr Pilette). Control subjects will be patients without CF and without evidence of lung disease and who are undergoing narcosis for an independent reason at the KULeuven centre.

Controls
Controls patients More than 18 years old Without CF Smokers or nonsmokers
Other: Lung explants
Lung explants from end-stage CF, which were obtained for a reason independent from the study in the Paris (Prof Burgel) and Leuven (Prof Dupont) centres will be analysed for pIgR and IgA expression as well as for Pseudomonas aeruginosa colonization. Some lung explants from control patients will also be obtained from the Leuven centre.

Other: Sputum, nasal fluid and serum
Sputum, nasal (fluid) and serum samples from CF patients and controls patients will be collected (Leuven, Paris, Torino, Verona and Saint-Luc Brussels) for S-IgA and microbiological assays. Spontaneous sputum will be collected, while nasal fluid will be sampled through nasal lavage. Control subjects will consist of COPD patients and healthy subjects (smokers or not).

Procedure: Bronchoscopy
Endobronchial biopsies (EBB) and broncho-alveolar lavage (BAL) will be sampled at the KULeuven centre (Prof Dupont) in some CF patients (homozygous for the DF508 mutation) and colonized or not with Pseudomonas aeruginosa and who must have a general anaesthesia for a reason independent from the study. In these patients, a bronchial endoscopy will be performed during narcosis to take EBB (n=8) and BAL (2x50mL). If possible, nasal and rectal biopsies will also be performed in some patients. Samples will be assessed for pIgR and IgA expression and for primary broncho-epithelial cultures (carried out at the UCL centre, Pr Pilette). Control subjects will be patients without CF and without evidence of lung disease and who are undergoing narcosis for an independent reason at the KULeuven centre.




Primary Outcome Measures :
  1. Evaluation of pIgR & IgA expression in bronchial tissue from CF patients, as compared to controls. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evaluation of S-IgA antibodies to respiratory bacteria in CF airways [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
  1. Lung explants from end-stage CF and control patients, which were obtained for a reason independent from the study.
  2. Sputum, nasal (fluid) and serum samples from CF patients and controls patients (COPD patients and healthy subjects) will be collected for S-IgA and microbiological assays. Spontaneous sputum will be collected, while nasal fluid will be sampled through nasal lavage.
  3. Endobronchial biopsies and broncho-alveolar lavage will be sampled in some CF patients who must have a general anaesthesia for a reason independent from the study. If possible, nasal and rectal biopsies will also be performed. Control subjects will be patients without evidence of lung disease and who are undergoing narcosis for an independent reason.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
CF patients followed in a CF center (UCL, KUL, Hôpital Cochin, Torino university) Controls patients (healthy volunteers for sputum or patients undergoing lung surgery for another reason).
Criteria

Inclusion Criteria:

CF: adult CF patients (from age 18) with a classical clinical phenotype related to DF508/DF508 mutation, and colonized or not with Pseudomonas aeruginosa

Exclusion Criteria:

  • <18 years
  • other chronic lung diseases except COPD as a specific control subgroup

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308267


Contacts
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Contact: Charles Pilette, MD, PhD +32 2 764 28 32 charles.pilette@uclouvain.be
Contact: Sophie Gohy, MD, PhD + 32 2 764 28 32 sophie.gohy@uclouvain.be

Locations
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Belgium
StLuc Recruiting
Brussels, Belgium, 1200
Contact: Sophie Gohy, MD, PhD    +32 2 764 28 32    sophie.gohy@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Charles Pilette, MD, PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02308267     History of Changes
Other Study ID Numbers: Forton2015
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Cystic Fibrosis
Mucosal immunity
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Immunoglobulin A, Secretory
Immunologic Factors
Physiological Effects of Drugs