- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963023
Biomarkers of Chronic Obstructive Pulmonary Disease (BIOBPCO)
August 22, 2023 updated by: Centre Hospitalier Universitaire, Amiens
Specific Biomarker Identification of Different Subgroups of Chronic Obstructive Pulmonary Disease
There are few studies about immunological explorations in COPD.
Because of the complications of lung biopsies, analyses are generally made on blood samples instead of lung tissue.
No study tried to classify COPD vs Asthma vs ACOS.
The investigators wondered if there were differences in biomarkers between these groups.
The investigators decided to open a pilot-study among COPD patients followed in Amiens-University Hospital.
Each patient will be examined and a blood-test will be performed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mélanie DRUCBERT, MD
- Phone Number: 03 22 04 59 10
- Email: drucbert.melanie@chu-amiens.fr
Study Contact Backup
- Name: Claire ANDREJAK, Pr
- Email: andrejak.claire@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
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
Sampling Method
Non-Probability Sample
Study Population
chronic obstructive pulmonary disease (COPD) patients, followed in Amiens-University Hospital
Description
Inclusion Criteria:
- BPCO patients
- ACOS patients
- asthmatic patient without BPCO
Exclusion Criteria:
- infection
- exacerbation
- immunosuppressive treatment
- immunosuppressive disease
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
frequent exacerbation patients
|
BPCO physical examinations
blood test in order to study immunologic markers
|
non frequent exacerbation patients
|
BPCO physical examinations
blood test in order to study immunologic markers
|
Asthma-and-COPD overlap syndrome
|
BPCO physical examinations
blood test in order to study immunologic markers
|
Asthmatic patients (without COPD)
|
BPCO physical examinations
blood test in order to study immunologic markers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
identification specific blood immunologic marker for COPD
Time Frame: one hour
|
COPD biomarkers are blood immunologic markers
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete blood count (CBC) Variation between COPD and asthmatic patients
Time Frame: one hour
|
one hour
|
c-reactive protein concentration variation between COPD and asthmatic patients
Time Frame: one hour
|
one hour
|
Plasma protein electrophoresis profile Variation between COPD and asthmatic patients
Time Frame: one hour
|
one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Actual)
June 15, 2021
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
June 17, 2021
First Submitted That Met QC Criteria
July 5, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Disease Attributes
- Bronchial Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Chronic Disease
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
Other Study ID Numbers
- PI2021_843_0051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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