NCT04304612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3.9 years

First QC Date

March 9, 2020

Last Update Submit

September 6, 2021

Conditions

HIVViral Hepatitis

Keywords

Serological assays

Outcome Measures

Primary Outcomes (1)

  • Number of Analytical performances

    Analytical performances

    day 1

Secondary Outcomes (1)

  • Number of Field evaluation

    day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • \- to refuse to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples without DNA : Three sample collections

Study Officials

  • Edouard TUAILLON

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Edouard TUAILLON, MD, PhD

CONTACT

467 338 469e-tuaillon@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

January 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

FR(1)