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

Study Overview
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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)).

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)．

Official Title
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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))

Conditions
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Magnetic Resonance Imaging Examination

Intervention / Treatment
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* Diagnostic Test: MRI,SCC-Ag


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| postmenopausal group<br> | Diagnostic Test: MRI,SCC-Ag<br>* Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen<br>|
| non-menopausal group<br> | Diagnostic Test: MRI,SCC-Ag<br>* Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen<br>|

What is the study measuring?
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Primary Outcome Measures

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