Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)

July 3, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University

Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of High-grade Cervical Squamous Neoplasia (Cervical Intra-epithelial Neoplasia Grades 2 and 3 (CIN 2/3))

The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

186 female patients with the HSIL(CIN2-3) were included in this study and followed up from the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical hysterectomy. Pathological findings of the patient's tissues were used as the final diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating characteristic curve (ROC)．

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The present study conformed to the declaration of Helsinki and was approved by the Ethics Committee of Second Affiliated Hospital of Wenzhou Medical University. we prospectively collected the data of patients with HSIL(CIN2-3) from March 1 to September 31, 2021, all patients included in this study were followed up from admission to discharge. A total of 186 patients were eligible and signed written informed consent.

Description

Inclusion Criteria:

  • No previous history of cervical lesions
  • TCT and HPV test results suspected cervical lesions
  • Further colposcopy showed HSIL or CIN 2-3
  • All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy

Exclusion Criteria:

  • Patients with receiving cold knife conization
  • Patients with skin squamous cell carcinoma or previous history of cancer
  • Pregnant women
  • Patients with serious heart, liver, kidney, blood system and autoimmune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
postmenopausal group
Diagnostic test: MRI,SCC-Ag
Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen
non-menopausal group
Diagnostic test: MRI,SCC-Ag
Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
Time Frame: 20 days
In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
20 days
the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
Time Frame: 20 days
In non-menopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: Zhao, The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SAHoWMU-CR2022-07-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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