RecruitingNCT05610098

Gene Expression Profiles in Spinal Tuberculosis.

Comparing Gene Expression Profiles of Adults With Isolated Spinal TB to Disseminated Spinal TB Identified by 18FDG-PET/CT at Time of Diagnosis, 6-and 12-months Follow-up


Sponsor

University of Cape Town

Enrollment

100 participants

Start Date

Oct 25, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615/100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain. In the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET/CT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at gene expression patterns in people who have tuberculosis of the spine (spinal TB). By studying which genes are active in these patients, researchers hope to better understand how the disease develops and progresses, and potentially identify markers that could help diagnose or monitor spinal TB more effectively. You may be eligible if: - You are 18 or older and weigh at least 40 kg - You have been diagnosed with spinal TB based on clinical and imaging findings - You are willing to be tested for HIV and to provide biological samples (including DNA/RNA) - You are willing to use a reliable method of pregnancy prevention during the study You may NOT be eligible if: - You are pregnant or planning to become pregnant in the next 6 months - You have uncontrolled diabetes - You have alcohol or drug abuse issues that could affect your participation - You have tested positive for COVID-19 in the past 4 weeks - There is a suspicion or known malignancy (cancer) on MRI - You have a suspected inflammatory or rheumatological condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05610098


Related Trials