Trials / Completed
CompletedNCT04995406
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis With the ISIT-TB Prototype in Adults Living in a High Burden Setting
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 722 (actual)
- Sponsor
- BioMérieux · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
Detailed description
This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ISIT-TB prototype | Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour |
Timeline
- Start date
- 2022-01-03
- Primary completion
- 2023-05-01
- Completion
- 2023-12-31
- First posted
- 2021-08-09
- Last updated
- 2024-03-08
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04995406. Inclusion in this directory is not an endorsement.