A Cost Effective and Time Saving Blood Test to Detect Six... | NCT04304612

Studies
A Cost Effective and Time Saving Blood Test to Detect Six Human Bloodborne Infectious Diseases

NCT04304612

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Sep 14, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

HIV
Viral Hepatitis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2021

Last Update Posted Date

Sep 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The consortium will develop a new in vitro diagnostic (IVD) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. The IVD test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. In this project, a mix of diagnostic protein markers will be developed and validated to lowdown an IVD test ready for commercial scale-up and CE-IVD certification.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Analytical performances	Analytical performances	day 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Field evaluation	Field evaluation	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Samples having been tested positive or negative for the serological markers explored in the study

Exclusion criteria:

- to refuse to participate to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Collection of human biological samples integrated into the laboratory's declared collections. These samples come from major subjects taken as part of a diagnostic or monitoring procedure for infection with viral hepatitis or HIV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Edouard TUAILLON, MD, PhD	Contact	467 338 469	33	e-tuaillon@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Edouard TUAILLON	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided