Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159270
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-17
Brief Title:
Infectious Prospective Collection for Biological Analysis
Sponsor:
CerbaXpert
Organization:
CerbaXpert
Study Overview
Official Title:
Collection of Prospective Biological Samples for Biological Analysis in Current Clinical Practice
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Infectieux1
Brief Summary:
The increase in activity within medical biology laboratories linked to the arrival of new markers in cardiology oncology infectious diseases etc and the acceleration of technical progress have created a prominent place for automated systems and their reagent kits within these establishments
It is in this context that CerbaXpert took the initiative to set up this research project for the collection of prospective biological samples and their analysis It transcribes both a process of continuous improvement but also scientific development making it possible to provide new andor complementary data in order to improve the operation of automated systems and their reagents within medical biology laboratories These data obtained in current practice via this study will also be compared with the technical information provided by the manufacturers of the reagents and their automatic devices
It is in this context that CerbaXpert took the initiative to set up this research project for the collection of prospective biological samples and their analysis It transcribes both a process of continuous improvement but also scientific development making it possible to provide new andor complementary data in order to improve the operation of automated systems and their reagents within medical biology laboratories These data obtained in current practice via this study will also be compared with the technical information provided by the manufacturers of the reagents and their automatic devices
Detailed Description:
This research protocol is a prospective multicenter collection of biological samples for evaluation of reagents and automated systems on the following parameters HAV B C D and E HIV HBV EBV CMV VZV HPV HSV polyomavirus family Chlamydia Trachomatis Neisseria gonorrhoeae Mycoplasma genitalium Trichomonas vaginalis Treponema pallidum Zika virus dengue fever chikungunya virus influenza virus Mycobacterium tuberculosis bacteria parasite responsible for toxoplasmosis malaria rubella virus Lyme borreliosis Sars-CoV-2 virus responsible for Covid-19 disease bacteria responsible for leptospirosis and salmonellosis the pathogens responsible for sepsis viruses bacteria or fungus and finally the Poxiviridae family This research is categorized as Research Involving Human Person level 3 RIPH 3 that is to say non-interventional carried out in current medical practice Recruitment will include a maximum of 22870 samples belonging to the following groups population general ambulatory patients hospitalized patients pregnant women dialysis patients and known population carrying the desired infectious agent
This protocol does not include special procedure for allocation or differential treatment for the subjects included there is neither randomization or treatment assigned to people participating in the study
The subjects recruited will be within several survey sites spread across the national territory the Cerballiance medical biology laboratories belonging to the Cerba HealthCare group Some clinical sites can be managed via a centralized collection site where a person is designated as principal investigator after qualification by the promoter and authorization from the Committee of Protection of People
Information relating to age sex date and place of sampling sample population of each subject general patients hospitalized patients pregnant women dialysis patients or patients known positive for one of the infectious agents targeted by this research protocol will be also varied Relevant medical data may also be compiled
1 the genotype of HAV B C D and E HIV HBV if available
2 the stage of the disease acute chronic cured
3 concomitant treatments linked to the pathology if available or which may interfere with the planned analysis
4 data relating to the participants lifestyle
5 date of onset of symptoms date of PCR test if applicable vaccination status date of vaccination name of vaccine number of injections batch number of vaccine
This protocol does not include special procedure for allocation or differential treatment for the subjects included there is neither randomization or treatment assigned to people participating in the study
The subjects recruited will be within several survey sites spread across the national territory the Cerballiance medical biology laboratories belonging to the Cerba HealthCare group Some clinical sites can be managed via a centralized collection site where a person is designated as principal investigator after qualification by the promoter and authorization from the Committee of Protection of People
Information relating to age sex date and place of sampling sample population of each subject general patients hospitalized patients pregnant women dialysis patients or patients known positive for one of the infectious agents targeted by this research protocol will be also varied Relevant medical data may also be compiled
1 the genotype of HAV B C D and E HIV HBV if available
2 the stage of the disease acute chronic cured
3 concomitant treatments linked to the pathology if available or which may interfere with the planned analysis
4 data relating to the participants lifestyle
5 date of onset of symptoms date of PCR test if applicable vaccination status date of vaccination name of vaccine number of injections batch number of vaccine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None