Chronic Obstructive BronchopneumopathyBRONCOLLNCT02788643
Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies
An observational study of Chronic Obstructive Bronchopneumopathy and Infectious Pneumonia, run by CHU de Reims at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Bronchopneumopathy, Infectious Pneumonia, Pneumonitis
- What is being tested?
- biological fluids (serum, bronchoalveolar lavage and pulmonary aspiration) and bronchial biopsies collection
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Not relevant
Who may be able to join
- 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)
Who cannot join
- Aged bellow 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- biological fluids (serum, bronchoalveolar lavage and pulmonary aspiration) and bronchial biopsies collection
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological fluids (serum, bronchoalveolar lavage and pulmonary aspiration) and bronchial biopsies collectionBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen expression
western blot and Reverse transcription polymerase chain reaction
Measured: 9 months
Collagen expression
western blot and Reverse transcription polymerase chain reaction
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive BronchopneumopathyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788643
- Sponsor's protocol ID
- PJ13017
- Acronym
- BRONCOLL
- Status last verified
- May 2021
- First submitted
- 20 May 2016
- Last updated
- 13 May 2021
- Results posted
- No
Publications
Dupont-Deshorgue A, Oudart JB, Brassart B, Deslee G, Perotin JM, Diebold MD, Monboisse JC, Ramont L, Brassart-Pasco S. A competitive enzyme-linked immunosorbent assay for quantification of tetrastatin in body fluids and tumor extracts. Anal Biochem. 2015 Aug 1;482:16-21. doi: 10.1016/j.ab.2015.04.023. Epub 2015 Apr 29.
PubMed 25935259
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies
- ClinicalTrials.gov ID
- NCT02788643
- Acronym / sponsor ID
- BRONCOLL / PJ13017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Not relevant
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Aged bellow 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological fluids (serum, bronchoalveolar lavage and pulmonary aspiration) and bronchial biopsies collection | Biological | – |
Primary outcome
Collagen expression
Time frame: 9 months
western blot and Reverse transcription polymerase chain reaction
Collagen expression
Time frame: 15 months
western blot and Reverse transcription polymerase chain reaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Background: PubMed 25935259Dupont-Deshorgue A, Oudart JB, Brassart B, Deslee G, Perotin JM, Diebold MD, Monboisse JC, Ramont L, Brassart-Pasco S. A competitive enzyme-linked immunosorbent assay for quantification of tetrastatin in body fluids and tumor extracts. Anal Biochem. 2015 Aug 1;482:16-21. doi: 10.1016/j.ab.2015.04.023. Epub 2015 Apr 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Bronchopneumopathy and Infectious Pneumonia, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collagen expression (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.