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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Wenzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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