Comparative Study of AI-assisted Cervical Cancer Detection (CerviAI) vs. Liquid-based Cytology Screening
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Vyuhaa Med Data Private Limited
- 入组人数
- 4,400
- 试验地点
- 3
- 主要终点
- To compare the diagnostic accuracy of CerviAI-Assisted detection of biopsy proven high-grade squamous abnormalities of the cervix (HSIL, ASC-H) as compared to manually reported LBC smears
概览
简要总结
This multicenter prospective trial compares CerviAI, an AI-assisted cervical cancer screening system, with manual liquid-based cytology. Its primary focus is on the diagnostic accuracy of CerviAI in detecting high-grade squamous intraepithelial lesions on LBC digitised slides, with secondary attention to detection of low-grade lesions and concordance with manual reporting. A total of 4,400 women aged 25–65 will be enrolled/recruited across AIIMS Jodhpur and SCB Cuttack over 12 months. Preclinical validation demonstrated high sensitivity and specificity, and this clinical assessment aims to confirm the efficacy, safety, and scalability of CerviAI in resource-constrained settings, enabling faster, affordable, and accessible cervical cancer screening.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 25-65 with no prior history of cervical cancer.
- •Patients within the screening age range who have undergone a supracervical hysterectomy.
- •Individuals over 65 years old without documented prior screening.
- •Vault smears are recommended for patients with a history of cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
排除标准
- •Pregnant women.
- •Women with a known history of cervical cancer or those undergoing chemotherapy/radiotherapy.
- •Patients who have undergone a hysterectomy.
结局指标
主要结局
To compare the diagnostic accuracy of CerviAI-Assisted detection of biopsy proven high-grade squamous abnormalities of the cervix (HSIL, ASC-H) as compared to manually reported LBC smears
时间窗: Index (CerviAI) and comparator (manual LBC) will be performed on the same LBC specimen at Day 0. Colposcopy and biopsy must occur within 50 days of sampling for positive cases
次要结局
- Diagnostic accuracy of CerviAI in detecting low-grade squamous intraepithelial lesions (LSIL) and atypical squamous cells of undetermined significance (ASCUS), compared to manual LBC reporting.(Assessed at the time of initial cervical screening and correlated with follow-up biopsy or repeat cytology/HPV triage during the 12-month study period.)
研究者
Dr Meenakshi Gothwal
AIIMS JODHPUR