An observational study in Tuberculosis, Extrapulmonary Tuberculosis and Mycobacterium Tuberculosis, sponsored by Nagasaki University. Recruiting at 2 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Nagasaki University · Observational
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 700 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Nagasaki University is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinically suspected of having TB lymphadenitis, TB pleuritis, and TB meningitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic accuracy of candidate biomarkers
Time frame: From enrollment to the end of treatment at 6 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nagasaki University