Actively Recruiting
Led by University of Cape Town · Updated on 2024-08-23
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
U
University of Cape Town
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
Tuberculosis (TB) is a leading cause of death worldwide, especially in Sub-Saharan Africa where both TB and HIV rates are high. This research focuses on spinal TB, also called Pott's disease, which causes severe spinal damage and affects vulnerable groups like children, people with HIV, and the elderly. The study aims to better understand spinal TB by examining its clinical features and gene expression patterns to help improve diagnosis and treatment. Researchers will use whole-body PET/CT scans alongside MRI to study the spread of spinal TB and identify gene expression profiles that distinguish isolated spinal TB from cases where the disease has spread to other organs. Patients diagnosed with spinal TB will undergo clinical exams, blood collection, sputum testing, and whole-body PET/CT scans at the start, 6 months, and 12 months. Samples from the spine and other affected sites will be collected if surgery occurs. Participants will be monitored for up to three years, with regular imaging and genetic testing to track disease progression and response to treatment. Researchers will evaluate gene expression profiles, compare PET/CT and MRI findings, analyze bacterial genomes, and observe changes over time using PET/CT. The goal is to develop better diagnostic tools, including a possible blood test, to identify and monitor spinal TB more effectively.
CONDITIONS
Gene Expression Profiles in Spinal Tuberculosis.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants receive MRI confirmation of spinal tuberculosis and undergo clinical examination, blood collection, HIV testing if needed, sputum collection, and screening for diabetes and pregnancy.
1 baseline visit (in-person)
Duration - 12 months
Participants undergo whole-body PET/CT scans at diagnosis, 6 months, and 12 months to monitor disease progression and treatment response. Additional samples may be collected if surgery is performed.
3 visits (in-person)
Duration - 3 years
Participants are observed over 3 years to analyze clinical phenotype, gene expression profiles, imaging findings, and genetic variability of spinal tuberculosis.
Follow-up visits as scheduled
Total: 1 location
1
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7935
Actively Recruiting
F
Friedrich F Thienemann, MD
M
Michael Held, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Julian Scherer, Sandra L Mukasa, Karen Wolmarans...
https://pubmed.ncbi.nlm.nih.gov/38918806