- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056404
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung (HYPERSENS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Allergic diseases are an important part of health concerns in Europe and in countries "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...).
As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens.
Associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss.
These clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. Diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed.
Using these criteria as predictors would increase opportunities to diagnose HP without using invasive clinical examinations such as biopsy and bronchoalveolar lavage.
Although serology is a useful argument for the diagnosis, its value is often criticized.
Thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another.
This issue could be raised by the use of recombinant antigens. The principle is to use only to the reaction the purified protein of interest produced by genetic engineering.
The Parasitology-Mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus the work of the team have identified proteins of interest for the diagnosis of two HP of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research.
For this project, the pigeon droppings (Columba livia), collected from different breeders in the region were identified as antigenic source.
The objective of the HYPERSENS project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. The aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Besançon, France, 25030
- Centre hospitalier régional universitaire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Exposure known about birds
- Non-smoker
- Absence of compatible respiratory symptoms with a HP
Exclusion Criteria:
- Farmer,
- smoker,
- pregnancy and feeding,
- minor subject,
- known immunizing deficit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: control subject
additional blood sample and 15 control subjects will be seen in consultations in the service of pneumology.
The visit will include an auscultation, a respiratory functional exploration and a blood test (2 tubes of 7 ml of total blood).
A questionnaire of exhibition will be realized to collect the species of birds and the times of exhibition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of protein of interest
Time Frame: 24 months
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5 and 15 proteins for all selected birds
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Selection and identification of protein of interest specific for each selected bird
Time Frame: 24 months
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Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).
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24 months
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Selection and identification of proteins of interest common to all selected bird'droppings
Time Frame: 24 months
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Identifying at least one common protein to all droppings of selected bird species by 2D-Electrophoresis and Western blotting.
This protein will be recognized by the antibodies of all patients regardless of their exposure and not recognized by controls.
It would make the diagnosis of BFL for any avian exposure.
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24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Laurence Millon, lmillon@chu-besancon.fr
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2015/66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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