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

S

Second Affiliated Hospital of Wenzhou Medical University

Status

Completed

Conditions

Magnetic Resonance Imaging Examination

Treatments

Diagnostic Test: MRI,SCC-Ag

Study type

Observational

Funder types

Other

Identifiers

NCT05487209
SAHoWMU-CR2022-07-204

Details and patient eligibility

About

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)).

Full 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).

Enrollment

186 patients

Sex

Female

Ages

26 to 82 years old

Volunteers

No 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

Trial design

186 participants in 2 patient groups

postmenopausal group
Treatment:
Diagnostic Test: MRI,SCC-Ag
non-menopausal group
Treatment:
Diagnostic Test: MRI,SCC-Ag

Trial contacts and locations

1

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Central trial contact

Yu Zhao, master

Data sourced from clinicaltrials.gov

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