Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients in Nairobi, Kenya (BioTube)

November 7, 2026 updated by: Nobuo Saito, Nagasaki University

Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients, in Nairobi, Kenya

Tuberculosis (TB) remains a global health threat with high incidence, especially in Africa. The proportion of extrapulmonary TB (EPTB) can escalate up to 36% in areas with a high HIV prevalence. Effectively managing and controlling EPTB in high-burden regions, such as Kenya, faces obstacles owing to the limitations of the current diagnostic tools. Traditional methods, such as smear microscopy and culture, often fail to detect EPTB due to the paucibacillary nature of the disease and while newer molecular techniques such as Xpert MTB/RIF have improved the diagnosis of pulmonary TB, they demonstrate reduced sensitivity for EPTB. The inadequacy of these tools results in delayed or missed diagnosis, contributing to higher morbidity and mortality. This underscores the urgent need for more sensitive, non-invasive diagnostic methods that can be applied in resource-limited settings like Kenya. This study aims to establish a biomarker-based diagnostic method for EPTB, using biomarkers such as lipoarabinomannan (LAM), MPT64, and Ag85B to diagnose and to monitor treatment response. Additionally, to clarify the characteristics and causative microorganisms of patients suspected of having TB but yielded negative results. Techniques such as ultrasensitive enzyme-linked immunosorbent assays (ELISA) and urine concentration methods will be employed to improve detection sensitivity. It also seeks to explore the extent of non-tuberculosis mycobacteria (NTM) and fungal infections in patients in patients presenting as presumed TB.

This prospective cohort study will be conducted at Kenyatta National Hospital and Mbagathi County Hospital in Nairobi, enrolling 763 adult patients with presumed extrapulmonary TB (EPTB) and 150 control participants from November 2024 to October 2028 Clinical and demographic data, along with sputum, blood, and urine samples, will be collected at enrolment for microbiological tests and biomarker analysis. The accuracy of biomarkers will be assessed by comparing their sensitivity and specificity against established diagnostic standards. For confirmed EPTB cases (n=50), follow-up samples will be collected during TB treatment to monitor biomarker trends alongside the patient's clinical progress.

This study can enhance EPTB diagnosis by evaluating the diagnostic profile of candidate biomarkers in urine or blood samples. The findings may lead to the development of accurate, non-invasive diagnostic tools suited for resource-limited settings, improving early detection and treatment outcomes. Additionally, by clarifying the epidemiological and microbiological profiles of TB, NTM, and fungal infections, the study could guide more targeted clinical management strategies, ultimately improving patient care in high-burden regions.

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.

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.
700

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 Locations

  • Kenya
      • Nairobi, Kenya
        • Recruiting
        • Kenyatta National Hospital
        • Contact:
      • Nairobi, Kenya
        • Recruiting
        • Mbagathi County Referral Hospital
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinically suspected of having TB lymphadenitis, TB pleuritis, and TB meningitis.

  • Clinically suspected TB lymphadenitis: Patients with one or more palpable lymph nodes (>20 mm in diameter) located in the cervical, axillary, or inguinal regions.
  • Clinically suspected TB pleuritis: Patients presenting with respiratory symptoms (e.g., dyspnea, cough, chest pain) along with radiographic evidence of pleural effusion.
  • Clinically suspected TB meningitis: Symptoms and signs of meningitis including one or more of the following, headache, irritability, vomiting, fever, neck stiffness, convulsions, focal neurological deficits, altered consciousness or lethargy.

Description

Inclusion Criteria:

  • Age 18 years and above
  • Clinically suspected active EPTB assessed by study clinicians
  • Patients with HIV with and without HIV infection
  • Patients whose samples can be collected from affected sites (such as lymph node aspirations and biopsies, pleural aspirations, and cerebral spinal fluid aspiration according to type of EPTB suspected)
  • Informed consent from patient

Exclusion Criteria:

  • Pregnant women: Due to complexities in follow-ups and obtaining samples
  • Patient with any type of cancer who is given anti-cancer treatment within the last one year or who has undergone surgery for cancer within the last one year
  • Patient who is taking immunosuppressive medications within the last one year: To minimize the impact medication-induced immune responses on TB disease progression and the accuracy of biomarker measurements
  • Patient who has anuria or oliguria and unable to provide 30-50ml of urine
  • Given TB treatment within one year: To avoid confounding effects from recent therapy
  • Patient who is mentally unstable

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Extrapulmonary tuberculosis

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
Sensitivity and specificity of biomarkers, such as lipoarabinomannan (LAM), MPT64, and antigen 85B (Ag85B) assays, for the diagnosis of extrapulmonary tuberculosis
Time Frame: From enrollment to the end of treatment at 6 months

Sensitivity and specificity, with 95% confidence intervals, will be estimated separately for each candidate biomarker assay. Biomarker results from specimens collected at enrolment will be evaluated against microbiological and clinical reference standards using the protocol-defined classifications of definite extrapulmonary tuberculosis, probable extrapulmonary tuberculosis, non-tuberculosis, and unclassified disease. Case classification will be performed at 6-8 weeks after enrolment.
From enrollment to the end of treatment at 6 months

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.
Nagasaki University

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.
April 8, 2025

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.
October 31, 2028

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.
March 30, 2030

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).
October 21, 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.
October 22, 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.
October 28, 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.
November 12, 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.
November 7, 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.
November 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.
  • KEMRI/SERU/CRDR/109/5040

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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