The Validity of the Use of Imaging in Cervical Cancer Staging
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Leon C Snyman, PhD
- Phone Number: +27834621818
- Email: leon.snyman@up.ac.za
Study Contact Backup
- Name: Edwin F Mnisi, MMed (O&G)
- Phone Number: +27766129797
- Email: edwinmnisi@hotmail.com
Study Locations
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Gauteng Province
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Pretoria, Gauteng Province, South Africa
- Kalafong Provincial Tertiary Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity
Time Frame: 2 years
|
Metrics of imaging
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cathy Visser, MSc, Trial administrator
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- 704/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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