Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of HSIL (CIN 2/3)
Study Details
Study Description
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)).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| postmenopausal group
|
Diagnostic Test: MRI,SCC-Ag
Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen
|
| non-menopausal group
|
Diagnostic Test: MRI,SCC-Ag
Magnetic Resonance Imaging examination,serum squamous cells carcinoma antigen
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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No previous history of cervical lesions
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TCT and HPV test results suspected cervical lesions
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Further colposcopy showed HSIL or CIN 2-3
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All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy
Exclusion Criteria:
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Patients with receiving cold knife conization
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Patients with skin squamous cell carcinoma or previous history of cancer
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Pregnant women
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Patients with serious heart, liver, kidney, blood system and autoimmune diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU | Wenzhou | Zhejiang | China | 325000 |
Sponsors and Collaborators
- Second Affiliated Hospital of Wenzhou Medical University
Investigators
- Principal Investigator: Zhao, The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Study Documents (Full-Text)
None provided.More Information
Publications
- Chen P, Jiao L, Ren F, Wang DB. Clinical value of serum squamous cell carcinoma antigen levels in predicting chemosensitivity, lymph node metastasis, and prognosis in patients with cervical squamous cell carcinoma. BMC Cancer. 2020 May 14;20(1):423. doi: 10.1186/s12885-020-06934-x.
- Fan A, Zhang L, Wang C, Wang Y, Han C, Xue F. Analysis of clinical factors correlated with the accuracy of colposcopically directed biopsy. Arch Gynecol Obstet. 2017 Nov;296(5):965-972. doi: 10.1007/s00404-017-4500-z. Epub 2017 Sep 9.
- Paavonen J, Naud P, Salmerón J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, Hedrick J, Jaisamrarn U, Limson G, Garland S, Szarewski A, Romanowski B, Aoki FY, Schwarz TF, Poppe WA, Bosch FX, Jenkins D, Hardt K, Zahaf T, Descamps D, Struyf F, Lehtinen M, Dubin G; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet. 2009 Jul 25;374(9686):301-14. doi: 10.1016/S0140-6736(09)61248-4. Epub 2009 Jul 6. Erratum in: Lancet. 2010 Sep 25;376(9746):1054.
- Sun X, Lei H, Xie X, Ruan G, An J, Sun P. Risk Factors for Residual Disease in Hysterectomy Specimens After Conization in Post-Menopausal Patients with Cervical Intraepithelial Neoplasia Grade 3. Int J Gen Med. 2020 Nov 10;13:1067-1074. doi: 10.2147/IJGM.S280576. eCollection 2020.
- Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14. Review.
- SAHoWMU-CR2022-07-204