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Completed

NCT Number: NCT05487209

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

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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Key information

Conditions

Magnetic Resonance Imaging Examination

Age range

26 year–82 year

Sex eligibility

Female

Study type

Observational

Primary location

The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, 325000, China

About this study

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)．

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI,SCC-Ag

Diagnostic Test

Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen

Primary outcomes

  1. The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women

    Time frame: 20 days

    In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results

  2. the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.

    Time frame: 20 days

    In non-menopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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))

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.