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

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))

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05487209

Enrollment

186

Registered

2022-08-04

Start date

2021-03-01

Completion date

2022-12-31

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnetic Resonance Imaging Examination

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)．

Interventions

DIAGNOSTIC_TESTMRI,SCC-Ag

Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

26 Years to 82 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026