A hospital biobank of leftover clinical samples to support rapid diagnostic tests for emerging infectious threats.
Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - DiagRaMIE Biobanque
This project will collect leftover samples from hospitalized adults to help test rapid diagnostic tools for emerging infectious diseases and CBRN threats.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 10 sites (Le Kremlin-Bicêtre and 9 other locations) |
| Trial ID | NCT07411729 on ClinicalTrials.gov |
What this trial studies
The DiagRaMIE Biobank is a multicenter prospective registry that systematically collects leftover clinical specimens (blood, serum, plasma, respiratory samples, urine, cerebrospinal fluid, biopsies) and linked pseudonymized clinical and microbiological data from hospitalized adults at Bicêtre and Paul Brousse over a three-year inclusion period. No extra procedures or visits are required; samples obtained during routine care are stored securely for up to 20 years. The resource is intended to support development and validation of in vitro rapid diagnostic tests for emerging infectious diseases and CBRN threats, including WHO-prioritized pathogens. Data and specimens will be accessible to qualified developers and researchers to accelerate test evaluation and strengthen epidemic preparedness and patient management.
Who should consider this trial
Good fit: Adults (≥18) hospitalized at Bicêtre or Paul Brousse with residual clinical samples available, covered by the French social security system, and able to provide written consent (or with a legal representative) are ideal candidates.
Not a fit: Patients not hospitalized at the participating centers, those without residual samples, individuals under judicial protection or deprived of liberty, or those unable to consent without a translator are unlikely to directly benefit from participation.
Why it matters
Potential benefit: If successful, the biobank could speed development and validation of rapid tests so infections are identified faster and outbreaks are controlled sooner.
How similar studies have performed: Hospital biobanks and specimen repositories have previously supported rapid development and validation of diagnostic tests (for example during COVID-19), although collections specifically focused on CBRN threats are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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.
Where this trial is running
Le Kremlin-Bicêtre and 9 other locations
- 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)
Study contacts
- Study coordinator: Thierry NAAS,, PhD
- Email: thierry.naas@aphp.fr
- Phone: 1 45 21 29 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.