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

Completed

• Conditions: Magnetic Resonance Imaging Examination
• Interventions: Diagnostic Test: MRI,SCC-Ag

• Registration Number: NCT05487209
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

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 Timeline

• Study Start: 2021-03-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-menopausal group	MRI,SCC-Ag	-
postmenopausal group	MRI,SCC-Ag	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU; 🇨🇳 Wenzhou, Zhejiang, China