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RecruitingNCT07411729Updated Feb 17, 2026

Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions

An observational study in Emerging Infectious Diseases, Communicable Diseases and Biological Warfare Agents, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

This multicenter prospective registry aims to establish a biobank of residual biological samples and associated clinical data from hospitalized patients. The registry will collect a wide range of specimens (serum, plasma, respiratory samples, urine, cerebrospinal fluid, biopsies) obtained during routine care, without any additional procedures. Data are pseudonymized and stored securely for up to 20 years. The biobank will be used to develop and evaluate rapid diagnostic tests (RDTs) for emerging infectious diseases and CBRN threats to improve epidemic preparedness and patient management.

Read the detailed description

The DiagRaMIE Biobank is designed to support the national strategy for emerging infectious diseases and CBRN (Chemical, Biological, Radiological, Nuclear) threats. Over a 3-year inclusion period, residual samples from routine care (e.g., blood, plasma, urine, cerebrospinal fluid, respiratory specimens, biopsies) will be systematically collected from eligible hospitalized patients in Bicêtre and Paul Brousse hospitals. Associated demographic, clinical, and microbiological data will be recorded in a secure electronic case report form (eCRF) and pseudonymized.

No additional procedures, visits, or interventions are required for participants. The biobank will provide a sustainable source of high-quality biological material and standardized data to enable the development, validation, and rapid deployment of in vitro rapid diagnostic tests (RDTs) targeting pathogens of major public health concern, including those prioritized by WHO (e.g., Yersinia pestis, Candida auris, Francisella tularensis, MERS-CoV, Nipah virus, Crimean-Congo hemorrhagic fever virus). This initiative aims to strengthen epidemic surveillance and preparedness and to ensure timely diagnostic capacity in future public health crises.

02

Conditions studied

  • Emerging Infectious Diseases
  • Communicable Diseases
  • Biological Warfare Agents
  • Zoonoses
  • Disease Outbreaks

Keywords

  • Blood and blood derivatives: whole blood, serum, plasma, cord blood
  • Microbiological specimens: positive blood cultures
  • Urine samples
  • Respiratory samples
  • expectorations
  • bronchoalveolar lavage (BAL)
  • protected distal samples
  • bronchial aspirations
  • Cerebrospinal fluid
  • Stool or rectal swabs
  • Skin or mucosal swabs
  • Biopsies and puncture material: lymph node, hepatic, gastric, or other tissue samples when available
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 800 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized in one of the participating study centers

Inclusion criteria

  • Adults (≥ 18 years old) hospitalized in one of the participating centers at Bicêtre or Paul Brousse hospitals, for whom residual biological samples are available as part of routine care in one or more participating hospital departments.
  • Covered by, or entitled to, the French social security system (excluding State Medical Aid - AME).
  • Patient or legal representative/trusted person informed about the registry and having provided written consent to participate.

Exclusion criteria

Exclusion Criteria:

  • Patients under judicial protection (guardianship or curatorship).
  • Patients deprived of liberty by judicial or administrative decision.
  • Patients not speaking French and not accompanied by a translator.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data

    Creation of a collection of residual biological samples (serum, plasma, urine, respiratory samples, CSF, biopsies, etc.) and associated clinical and microbiological data obtained during routine care

    Time frame: 36months (end of patient inclusion period)

07

Study locations

10 of 10 sites recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
    Recruiting
  • CHU Paul Brousse
    Villejuif, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07411729
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
NG Biotech, Commissariat A L'energie Atomique
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Jun 3, 2024
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Feb 17, 2026

Study contacts

Thierry NAAS,, PhD
Contact
thierry.naas@aphp.fr
1 45 21 29 86 ext. +33
Saoussen OUESLATI, PhD
Contact
saoussen.oueslati@aphp.fr
1 45 21 29 86 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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