Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool for cervical cancer based on the assessment of digital images through artificial intelligence. Several teams around the world have developed versions of AVE as a triage technology but none as a screening tool.
详细描述
BACKGROUND:
Cervical cancer, caused by persistent infection of carcinogenic types of the human papillomavirus (HPV), is the second leading cause of female cancer in El Salvador. Effective screening and treatment of precancerous lesions have lowered cervical cancer rates in high-income countries, but the disease remains a leading cause of death in low-and middle-income countries (LMICs). Currently, up to 80% of the disease burden and 90% of global deaths occur in LMICs primarily due to lack of resources and poor infrastructure. A new test, Automated Visual Evaluation (AVE), is a point-of-care screening and triage diagnostic tool based on the assessment of digital images through artificial intelligence.
The purpose of this study is to validate Automated Visual Evaluation (AVE), specifically the CINFinder version developed by DL Analytics, a point-of-care screening and triage diagnostic tool based on the assessment of digital images through artificial intelligence. AVE has been in development since 2021. The current study will consist of a clinical trial to compare the sensitivity of AVE (CINFinder version) with traditional screening and triage tests.
STUDY DESIGN:
This is a prospective paired interventional study of 10,000 women in San Salvador, El Salvador, to test the difference in sensitivities between AVE (CINFinder) and with other screening and triage tests, including HPV tests and unaided visual inspection with acetic acid (VIA) to detect CIN2+ as a primary screening method. As a secondary aim, investigators will also validate the use of AVE as a triage test in patients with positive HPV results. Histopathology diagnosis will be used as the reference to determine true disease status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 30 and 59 years of age
排除标准
- •Pregnancy at the time of colposcopy/biopsy
- •Hysterectomy with surgically absent cervix
- •HPV test in the last 5 years independently of negative or positive result
- •Previous cervical cancer diagnosis or treatment in the last 5 years
- •Lack of willingness or capacity to provide informed consent
研究组 & 干预措施
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: HPV Test (Diagnostic Test)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: EVA System (Device)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Visual Inspection with Acetic Acid (VIA) (Procedure)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Automated Visual Evaluation (AVE) (Diagnostic Test)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Image Capture with Mobile Phone (Other)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Pregnancy test (Diagnostic Test)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: ScreenFire HPV test (Diagnostic Test)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Colposcopy with biopsy (Procedure)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Thermal Ablation (Procedure)
Experimental
Women eligible for HPV screening based on El Salvador's national guidelines will receive careHPV, VIA, and AVE (active comparator).
Screen-positive women by HPV, VIA or AVE referred to colposcopy clinic and 5% of screen-negative women (negative on HPV, VIA, and AVE).
Cervical cancer triage and diagnostic tests among screen- positive women and screen negative women.
Biopsy-confirmed positive will receive necessary treatment by local standard of care.
干预措施: Loop electrosurgical excision procedure (LEEP) (Procedure)
结局指标
主要结局
Sensitivity
时间窗: 12 months, non-randomized
Proportion of true CIN2+ positive cases based on biopsy, detected by AVE compared to VIA.
Positive Predictive Value (PPV)
时间窗: 12 months, non-randomized
Proportion of participants with AVE positive tests that have cervical precancer based on biopsy compared to those with positive VIA positive tests
次要结局
未报告次要终点