Clinical trial · Observational
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))
NCT05487209CI-TRIAL-00067813completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Magnetic Resonance Imaging Examination | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI,SCC-Ag | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- postmenopausal group
- interventionNames
- Diagnostic Test: MRI,SCC-Ag
- label
- non-menopausal group
- interventionNames
- Diagnostic Test: MRI,SCC-Ag
Primary outcomes (2)
- measure
- The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
- timeFrame
- 20 days
- description
- In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
- measure
- the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 82 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDTorre 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. PMID 26667886
- BACKGROUNDPaavonen J, Naud P, Salmeron 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. PMID 19586656
- BACKGROUNDFan 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. PMID 28889237
- BACKGROUNDSun 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. PMID 33204141
- BACKGROUNDChen 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. PMID 32410650