Cervical Cancer Stage, Imaging ModalitiesNCT06487767
The Validity of the Use of Imaging in Cervical Cancer Staging
An observational study of Cervical Cancer Stage, Imaging Modalities, run by University of Pretoria at 1 site in South Africa.
Trial summary
The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Stage, Imaging Modalities
- What is being tested?
- Surgery
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women diagnosed with cervical cancer scheduled for surgical treatment or intervention
Who may be able to join
- Women diagnosed with cervical cancer Able and willing to provide informed consent
Who cannot join
- Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site
Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng
About this study
The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer
Read the 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.
- Being tested
- Surgery
- Keywords
- Cervical cancer, Ultrasound, MRI, CT Scan, PET-CT scan
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Surgery for operable cervical cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Metrics of imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Stage, Imaging ModalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Edwin Mnisi, Prof Mike Sathekge, Prof N Khan
- Responsible party
- Principal investigator, Leon Snyman, University of Pretoria
- Investigators
- Cathy Visser, MSc, Study director, Trial administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487767
- Sponsor's protocol ID
- 704/2023
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of the Use of Imaging in Cervical Cancer Staging
- ClinicalTrials.gov ID
- NCT06487767
- Acronym / sponsor ID
- 704/2023
- Keywords
- Cervical cancer, Ultrasound, MRI, CT Scan, PET-CT scan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Collaborators
- Dr Edwin Mnisi, Prof Mike Sathekge, Prof N Khan
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with cervical cancer scheduled for surgical treatment or intervention
Key inclusion criteria (1 listed)
- Women diagnosed with cervical cancer Able and willing to provide informed consent
Key exclusion criteria (2 listed)
- Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgery for operable cervical cancer | Other | – |
Primary outcome
Sensitivity and specificity
Time frame: 2 years
Metrics of imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer Stage, Imaging Modalities
RecruitingPhase 1
Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cathy Visser, MSc study director
Trial administrator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer Stage, Imaging Modalities, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edwin F Mnisi, MMed (O&G) (+27766129797, edwinmnisi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.