Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer

Summary

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.

Conditions

• Human Papillomavirus (HPV)
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Neoplasms
• Cervical Cancers

Interventions

DIAGNOSTIC_TEST

HPV Test

The 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.

DEVICE

EVA System

Digital colposcope

PROCEDURE

Visual Inspection with Acetic Acid (VIA)

unaided visual inspection with acetic acid

DIAGNOSTIC_TEST

Automated Visual Evaluation (AVE)

Digital diagnostic classification, quality classifier using captured images from EVA System

OTHER

Image Capture with Mobile Phone

Compare performance of AVE installed on a mobile phone vs. on the EVA System

DIAGNOSTIC_TEST

Pregnancy test

Urine based pregnancy test

DIAGNOSTIC_TEST

ScreenFire HPV test

ScreenFire 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.

PROCEDURE

Colposcopy with biopsy

A 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.

PROCEDURE

Thermal Ablation

Thermal 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.

PROCEDURE

Loop electrosurgical excision procedure (LEEP)

LEEP 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).

Sponsors & Collaborators

• Basic Health International

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• DL Analytics

  lead INDUSTRY

Principal Investigators

• Karla Alfaro, MD · Basic Health International

• David Levitz, PhD · DL Analytics

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

59 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-12

Primary Completion

2026-07-31

Completion

2026-12-31

Countries

• El Salvador

Study Locations