Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung (HYPERSENS)
Primary Purpose
Avian Hypersensitivity Pneumonitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood sample
respiratory functional exploration
Sponsored by
About this trial
This is an interventional other trial for Avian Hypersensitivity Pneumonitis
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Régional Universitaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
control subject
Arm Description
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.
Outcomes
Primary Outcome Measures
number of protein of interest
5 and 15 proteins for all selected birds
Secondary Outcome Measures
Selection and identification of protein of interest specific for each selected bird
Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).
Selection and identification of proteins of interest common to all selected bird'droppings
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.
Full Information
NCT ID
NCT03056404
First Posted
August 10, 2016
Last Updated
November 19, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03056404
Brief Title
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Acronym
HYPERSENS
Official Title
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
September 28, 2016 (Actual)
Study Completion Date
September 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avian Hypersensitivity Pneumonitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control subject
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
additional blood sample
Intervention Type
Other
Intervention Name(s)
respiratory functional exploration
Primary Outcome Measure Information:
Title
number of protein of interest
Description
5 and 15 proteins for all selected birds
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Selection and identification of protein of interest specific for each selected bird
Description
Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).
Time Frame
24 months
Title
Selection and identification of proteins of interest common to all selected bird'droppings
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Millon
Organizational Affiliation
lmillon@chu-besancon.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besançon
ZIP/Postal Code
25030
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28760669
Citation
Rouzet A, Reboux G, Dalphin JC, Gondouin A, De Vuyst P, Balliau T, Millon L, Valot B, Roussel S. An immunoproteomic approach revealed antigenic proteins enhancing serodiagnosis performance of bird fancier's lung. J Immunol Methods. 2017 Nov;450:58-65. doi: 10.1016/j.jim.2017.07.012. Epub 2017 Jul 29.
Results Reference
derived
Learn more about this trial
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
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