Gene expression profiles in spinal tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the clinical phenotype of spinal tuberculosis (TB) using whole body PET/CT imaging and to identify specific gene expression profiles associated with different stages of the disease. The researchers hypothesize that spinal TB can present as either isolated or disseminated forms, and that these can be distinguished by gene expression patterns. By comparing findings with previously established signatures for pulmonary TB, the study seeks to improve diagnostic methods and treatment monitoring for spinal TB, particularly in populations with high HIV prevalence.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing
2. TB spine based on clinical and radiological criteria
3. Age 18 or older with a body weight of at least 40 kg body weight
4. Able and willing to return to follow-up
5. Willing to have samples, including DNA including RNA extraction, stored
6. Willing to consistently practice a highly reliable method of pregnancy prevention

Exclusion Criteria

1. Pregnancy or active desire to become pregnant within the next 6 months.
2. Uncontrolled diabetes (HbA1c ≥ 6.5% / random glucose concentration ≥11.1 mmol/l, fasting plasma glucose ≥ 7.0 mmol/l)
3. Alcohol and substance abuse which might interfere with medication adherence during the trial
4. Positive SARS-CoV-2 PCR in the past 4 weeks
5. Suspicion of malignancy on MRI or known malignancy
6. Suspicion of inflammatory disease and other rheumatological conditions
7. Any person for whom the physician feels this study is not appropriate

Where it's running

• Groote Schuur Hospital
  Cape Town, Western Cape, South Africa Recruiting

Study contacts

• Principal investigator: friedrich Thienemann, MD — University of Cape Town
• Study coordinator: Friedrich F Thienemann, MD
• Email: friedrich.thienemann@uct.ac.za
• Phone: +27 (0)21 406 6358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.