Study of Gene Expression and Imaging in Adults With Spinal Tuberculosis Comparing Isolated and Disseminated Forms Using PETCT and MRI
Assessing Treatment and Disease Patterns Over 12 Months
Led by University of Cape Town · Updated on 2024-08-23
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
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 Potts 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 PETCT 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 PETCT 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 PETCT and MRI findings, analyze bacterial genomes, and observe changes over time using PETCT. The goal is to develop better diagnostic tools, including a possible blood test, to identify and monitor spinal TB more effectively.
CONDITIONS
Brief Title
Gene Expression Profiles in Spinal Tuberculosis.
Research Team
F
Friedrich F Thienemann, MD
M
Michael Held, MD
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Alcohol or substance abuse that may interfere with medication adherence
Positive COVID-19 test within the past 4 weeks
Suspicion or known diagnosis of cancer
Suspicion of inflammatory or other rheumatological diseases
Any condition that the physician considers makes participation inappropriate
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
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)
Monitoring
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)
Long-term Monitoring
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
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Comparing gene expression profiles of adults with isolated spinal tuberculosis to disseminated spinal tuberculosis identified by 18FDG-PET/CT at time of diagnosis, 6- and 12-months follow-up: classifying clinical stages of spinal tuberculosis and monitoring treatment response (Spinal TB X cohort study).
Julian Scherer, Sandra L Mukasa, Karen Wolmarans...