Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions

February 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - DiagRaMIE Biobanque

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Le Kremlin-Bicêtre, France
      • Villejuif, France
        • Recruiting
        • CHU Paul Brousse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in one of the participating study centers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data
Time Frame: 36months (end of patient inclusion period)
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
36months (end of patient inclusion period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Commissariat A L'energie Atomique
NG Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP 230322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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