Clinical trial NCT05487209: Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)
Official 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))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging Examination
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 186
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study conformed to the declaration of Helsinki and was approved by the Ethics Committee of Second Affiliated Hospital of Wenzhou Medical University. we prospectively collected the data of patients with HSIL(CIN2-3) from March 1 to September 31, 2021, all patients included in this study were followed up from admission to discharge. A total of 186 patients were eligible and signed written informed consent.

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)．

Eligibility criteria: 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

Primary outcomes:
measure: The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
timeFrame: 20 days
measure: the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
state: Zhejiang
Study officials:
affiliation: The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
name: Zhao
role: PRINCIPAL_INVESTIGATOR
References:
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