NCT05610098Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 24 Oct 2022
- Start date
- 25 Oct 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Cape Town
- Diseases
- Tuberculosis
- NCT number
- NCT05610098
What you commit to
- Study type: Observational
- Planned participants: 100
- From 25 Oct 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol and substance abuse which might interfere with medication adherence during the trial
Other illness
- Suspicion of malignancy on MRI or known malignancy
- Suspicion of inflammatory disease and other rheumatological conditions
Lab values
- Uncontrolled diabetes (HbA1c ≥ 6.5% / random glucose concentration ≥11.1 mmol/l, fasting plasma glucose ≥ 7.0 mmol/l)
Other
- Pregnancy or active desire to become pregnant within the next 6 months.
- Positive SARS-CoV-2 PCR in the past 4 weeks
- Any person for whom the physician feels this study is not appropriate
Who the study is looking for
- Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing
- TB spine based on clinical and radiological criteria
- Age 18 or older with a body weight of at least 40 kg body weight
- Able and willing to return to follow-up
- Willing to have samples, including DNA including RNA extraction, stored
- Willing to consistently practice a highly reliable method of pregnancy prevention
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.