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The development and application of noninvasive intelligent auxiliary diagnosis system for cervical cancer screening and risk factors prediction based on multi-parameter MRI

The development and application of noninvasive intelligent auxiliary diagnosis system for cervical cancer screening and risk factors prediction based on multi-parameter MRI

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038857
Enrollment
Unknown
Registered
2020-10-07
Start date
2020-10-10
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

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Sponsors

Jinshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) High risk HPV infection group: 500 patients, high-risk type of HPV DNA test, pathological examination showed no cervical intraepithelial neoplasia and cancer. 2) Cervical intraepithelial neoplasia group: 500 cases, the patients were pathologically confirmed as cervical intraepithelial neoplasia I-III. 3) Cervical cancer group: 600 FIGO IA stage patients, 1500 FIGO IB stage patients, 600 FIGO IIA1 stage patients and 600 patients with advanced cervical cancer (IIA2, IIB, IIIC) who can be resected by surgery. All patients with cervical cancer: 1. Pathological type, tumor volume, internal os involvement, lymph-vascluar invasion, stromal invasion, parauterine invasion and lymph node metastasis were confirmed by postoperative pathological results. 2. Radical hysterectomy combined with lymph node dissection was performed. 3. The patients underwent surgery within 30 days after standard MRI examination. Patients in above groups, 1. MRI scan should include the following sequences: T1 Weighted Imaging, T2 Weighted Fat Suppression Imaging, Diffusion Weighted Imaging, Apparent Diffusion Coefficient Map and Contrast-Enhanced T1 Weighted Imaging. 2. MRI scan was completed within 7 days before biopsy. 3. The clinicopathological information of all subjects was available.

Exclusion criteria

Exclusion criteria: 1. Preoperative adjuvant chemotherapy or radiotherapy. 2. Biopsy was performed before MRI scanning, and the interval between biopsy and MRI scanning was less than 7 days. 3. Poor imaging quality.

Design outcomes

Primary

MeasureTime frame
Area under curve;Sensitivity;Specificity;Accuracy;

Countries

China

Contacts

Public ContactYongai Li

Jinshan Hospital Affiliated to Fudan University

pingyaoaiai@163.com+86 18930819945

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026