TuberculosisBioTubeNCT07901387
Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients in Nairobi, Kenya
An observational study of Tuberculosis and Extrapulmonary Tuberculosis, run by Nagasaki University at 2 sites in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Extrapulmonary Tuberculosis, Mycobacterium Tuberculosis
- How many people
- 700 participants
- Where
- 2 sitesKenya
- Study dates
- 8 Apr 2025to 30 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya2 sites, 2 recruiting
- Recruiting
Kenyatta National Hospital
Nairobi
Nobuo Saito, MD, PhD, +254773406090, nsaito@nagasaki-u.ac.jp
- Recruiting
Mbagathi County Referral Hospital
Nairobi
Nobuo Saito, MD, PhD, +254773406090, nsaito@nagasaki-u.ac.jp
About this study
Official title: 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.
- Keywords
- Tuberculosis, Diagnosis, Extrapulmonary tuberculosis, Biomarker, Lipoarabinomannan, transrenal DNA
- Medical subject headings
- Tuberculosis, Tuberculosis, Extrapulmonary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extrapulmonary tuberculosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of candidate biomarkers
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start8 Apr 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuo Saito, Nagasaki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901387
- Sponsor's protocol ID
- KEMRI/SERU/CRDR/109/5040
- Acronym
- BioTube
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients, in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT07901387
- Acronym / sponsor ID
- BioTube / KEMRI/SERU/CRDR/109/5040
- Keywords
- Tuberculosis, Diagnosis, Extrapulmonary tuberculosis, Biomarker, Lipoarabinomannan, transrenal DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extrapulmonary tuberculosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of candidate biomarkers
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Extrapulmonary Tuberculosis, run by Nagasaki University at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nobuo Saito, MD, PhD (+2540773406090, nsaito@nagasaki-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of candidate biomarkers (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.