Tuberculosis, Pulmonary
Conditions
Interventions
This is a study for the development of a diagnostic test in phases I and II. The general objective of the study is to test the ability of previously identified cellular and molecular markers to diagno
C01.150.252.410.040.552.846.899
Sponsors
Instituto Gonçalo Moniz (IGM) da Fundação Oswaldo Cruz (FIOCRUZ)
Instituto Gonçalo Moniz (IGM) da Fundação Oswaldo Cruz (FIOCRUZ)
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants with respiratory symptoms; men and women aged between 18 and 65 years (including) at the moment of informed consent; respiratory symptoms as a reason for seeking assistance at the Octávio Mangabeira Specialized Hospital (HEOM). Healthy participants; men and women aged between 18 and 65 years (inclusive) at the time of informed consent; postgraduate students, technicians, and/or researchers from the Gonçalo Moniz Institute (IGM), Fiocruz-Ba; absence of respiratory symptoms or acute illnesses in the last 14 days.
Exclusion criteria
Exclusion criteria: Participants with respiratory symptoms; individuals under 18 years old and over 65 years old; using systemic corticosteroids; who have had a previous diagnosis and/or treatment for pulmonary TB in the last two years; transplant recipients, undergoing cancer treatment, or having autoimmune diseases. Healthy participants; presence of respiratory symptoms or acute illnesses in the last 14 days; previous diagnosis and/or treatment for pulmonary TB in the last two years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The text you provided discusses the standardization of a diagnostic marker detection assay for tuberculosis (TB) (edTB) through the stimulation of whole blood with the apolar lipid extract of Mycobacterium tuberculosis (Mtb) at 0.05 mg/mL for 48 and 72 hours at 37°C and 5% CO2. It involves individuals with pulmonary tuberculosis (n = 15) and healthy controls (n = 15). The outcome measure is the enzyme-linked immunosorbent assay (ELISA) for quantifying TNF in the culture supernatants. So far, seven individuals with TB and seven healthy individuals have been recruited. Their whole blood samples were used for cultures with the apolar lipid extract. The 48-hour incubation with 0.05 mg/mL of apolar lipid extract has shown to be the best culture condition. Notably, the average production of TNF in the TB group appears to be twice as high as in the cells of healthy individuals. However, the 72-hour incubation is not showing specific TNF production by the lipids. The validation of molecular markers for the diagnosis of pulmonary tuberculosis was conducted in a population of 75 symptomatic respiratory participants, including 27 participants with pulmonary tuberculosis and 48 symptomatic respiratory participants. The analyses revealed differences in the expression levels of the genes FCGR1A, PDCD1LG2, and GBP5 between the evaluated groups, while no difference was observed for the IRAK3 gene. Receiver Operating Characteristic (ROC) curve analyses were performed to assess the area under the curve (AUC) for subsequent performance parameter evaluation. The AUC values, sensitivity, specificity, and accuracy for different genes were presented. In addition to AUC, other diagnostic parameters were evaluated, such as Likelihood Ratio, Odds Ratio Difference (ORD), and Kappa Index. | — |
Secondary
| Measure | Time frame |
|---|---|
| The validation of this data is expected to contribute to the development of new diagnostic tests for tuberculosis, which can be used as screening tools in places where the molecular rapid test (TRM-TB) is not accessible due to its high cost. | — |
Countries
Brazil
Contacts
Public ContactAdriano Silva
Instituto Gonçalo Moniz (IGM) da Fundação Oswaldo Cruz (FIOCRUZ)
Outcome results
None listed