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.
Women between 30 and 59 years of age
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
Single group
HPV Test
Diagnostic testThe careHPV (QIAGEN, Gaithersburg, MD) test was developed in a public-private partnership specifically for use in low-resource settings. It is a simplified, robust, and affordable HPV test that does not distinguish specific HPV types; rather, it gives a positive result if any of 14 hrHPV types is present in the specimen. Electricity is necessary to run the test, but it does not need running water or air conditioning. In order to be most cost effective, the samples must be run with a full plate of 96 samples. Results take 3-4 hours to complete.
EVA System
DeviceDigital colposcope
Visual Inspection with Acetic Acid (VIA)
Procedure/Surgeryunaided visual inspection with acetic acid
Automated Visual Evaluation (AVE)
Diagnostic testDigital diagnostic classification, quality classifier using captured images from EVA System
Image Capture with Mobile Phone
Other interventionCompare performance of AVE installed on a mobile phone vs. on the EVA System
Pregnancy test
Diagnostic testUrine based pregnancy test
ScreenFire HPV test
Diagnostic testScreenFire HPV test (Atila BioSystems, Inc, Mountain View, CA) uses isothermal amplification to detect 13 high risk (hr)HPV types directly from clinical samples in approximately one hour. The test can be run on any real-time PCR machine and gives separate results for hrHPV types 16 and 18, as well as a pooled positive result for 13 other hrHPV types. The human cellular gene beta-globin is used as an internal control to measure sample adequacy. ScreenFire can be self-collected and does not require batching. AmpFire® obtained CE-mark in 2017.
Colposcopy with biopsy
Procedure/SurgeryA colposcopic exam with biopsy entails visual magnification of the cervix and the removal of a small piece of cervical tissue. After the application of acetic acid 5% onto the cervix, a device called a colposcope allows the clinician to visually identify changes consistent with HPV. Areas of the cervix where lesions appear (or if not, randomly selected sections) are then biopsied (small piece of sample removed) and an endocervical curettage is performed (removing a small section from the inside of the cervix). Tissue specimens are then sent to the lab for pathology diagnosis.
Thermal Ablation
Procedure/SurgeryThermal ablation is utilized to treat high-grade cervical precancer. First, a speculum is introduced into the vagina to identify the cervix. Acetic acid 5% is applied to the cervix for one minute and the cervix is observed to look for changes consistent with precancer. If the cervix is able to be fully evaluated and there are no signs of invasive cancer, the tip of the device is heated to 100ºC and applied directly to the cervix for 1-2 minutes, which ablates or destroys the abnormal cells.
Loop electrosurgical excision procedure (LEEP)
Procedure/SurgeryLEEP is utilized to remove abnormal tissue from the cervix. This may include tissue with precancerous cells (called cervical dysplasia) or cancerous cells. The loop is heated using electricity to remove the tissue. LEEP may also be called a loop excision or large loop excision of the transformation zone (LLETZ).
Sensitivity
Proportion of true CIN2+ positive cases based on biopsy, detected by AVE compared to VIA.
Positive Predictive Value (PPV)
Proportion of participants with AVE positive tests that have cervical precancer based on biopsy compared to those with positive VIA positive tests
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DL Analytics
Lead sponsor
Basic Health International, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator