The Validity of the Use of Imaging in Cervical Cancer Staging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery.
- Who it may be relevant to
- Registry conditions: Cervical Cancer Stage, Imaging Modalities. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer
Detailed description
Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists.
CT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed.
The sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.
Interventions
- Other Surgery
Surgery for operable cervical cancer
Primary outcome measures
- Sensitivity and specificity [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
\- Women diagnosed with cervical cancer Able and willing to provide informed consent
Exclusion criteria
Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
South Africa · 1 center
- Kalafong Provincial Tertiary Hospital — Pretoria
Identifiers
NCT: NCT06487767 · 704/2023