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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

Brief Summary

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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)).

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Detailed Description

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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)．

Conditions

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Magnetic Resonance Imaging Examination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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postmenopausal group

MRI,SCC-Ag

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

non-menopausal group

MRI,SCC-Ag

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

Interventions

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MRI,SCC-Ag

Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

26 Years

Maximum Eligible Age

82 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No