Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies (BRONCOLL)

May 12, 2021 updated by: CHU de Reims

Collagens are proteins present in all tissues. Besides their structural role, recent data showed that they were able to regulate many cellular functions. Many interactions occur between extracellular matrix macromolecules, especially collagen, and various cell types. These interactions can be controlled by peptides derived extracellular matrix macromolecules, called matrikines. Previous work from the investigators laboratory and others have shown that several C-terminal domain (NC1 domains) from basement membrane-associated collagens could regulate many cellular activities.

Lung is an organ particularly abundant in basement membranes. It is likely that various lung diseases may affect metabolism of basement membrane associated collagens. To the investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in various pathophysiological situations.

The aim of this study are to:

  • Study the presence of collagen IV and XIX (or fragments) in different types of sampling such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies
  • Evaluate quantitative variations of expression of these collagen in different pulmonary diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia, pneumonitis or lung cancer.

Study Overview

Detailed Description

Experimental Design: Cross-sectional study, with prospective inclusions, single center.

Investigations:

  • Realization of bronchoscopy according to the indications (with or without bronchoalveolar lavage with or without bronchial biopsy, participation in research that do not modify patient's care)
  • samples are sent to the laboratory, centrifuged and stored at -80°C until they were assessed.
  • samples were used to specific analysis in this study:
  • Study of qualitative expression of collagen IV and XIX by Reverse transcription polymerase chain reaction (RT-PCR) and Western Blot
  • Study of quantitative variations of these collagens by ELISA

Statistical analysis planification:

  • description of the data (mean and standard deviation),
  • comparison of different groups (non-pathological vs pulmonary disease) by Student's t test, Wilcoxon, Chi2 or Fisher test.

Expected results and prospects:

The investigators should be able to demonstrate the presence of collagen IV and/or collagen XIX or different fragments in biological samples. The investigators would then be able to show variation in expression of these collagens according to different pathological situations. In the longer term, the objective is to validate these collagens as a markers of pulmonary pathologies or as therapeutic agents.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reims, France, 51092
        • CHU Reims

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

Not relevant

Description

Inclusion Criteria:

  • Patient from the division of pulmonary medicine of the Reims University Hospital
  • Patient that must undergo a bronchoscopy with bronchoalveolar lavage
  • Male or female
  • Informed of the study (written information) and not objecting to it (oral agreement)

Exclusion Criteria

- Aged bellow 18 years

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collagen expression
Time Frame: 9 months
western blot and Reverse transcription polymerase chain reaction
9 months
Collagen expression
Time Frame: 15 months
western blot and Reverse transcription polymerase chain reaction
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

May 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (ESTIMATE)

June 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

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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