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

ConditionsHuman Papillomavirus (HPV)Cervical Intraepithelial Neoplasia Uterine Cervical Neoplasms Cervical Cancers

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age30-59

SponsorDL Analytics

About this trial

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.

Eligibility criteria

Qualifiers

Women between 30 and 59 years of age

Disqualifiers

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

Trial design

Treatments tested in this trial

HPV Test
EVA System
Visual Inspection with Acetic Acid (VIA)
Automated Visual Evaluation (AVE)
Image Capture with Mobile Phone
Pregnancy test
ScreenFire HPV test
Colposcopy with biopsy
Thermal Ablation
Loop electrosurgical excision procedure (LEEP)

Treatment groups

10,000 Participants

are divided into 1 treatment group

Sponsors and collaborators

DL Analytics

Lead sponsor

Basic Health International, Inc.

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov