Clinical trial · Interventional
Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer
Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer: Automated Visual Evaluation
NCT06815939CI-TRIAL-00101993OPTICSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Papillomavirus (HPV) | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Visual Evaluation (AVE) | Diagnostic Test | — | UNRESOLVED |
| Colposcopy with biopsy | Procedure | — | UNRESOLVED |
| EVA System | Device | — | UNRESOLVED |
| HPV Test | Diagnostic Test | — | UNRESOLVED |
| Image Capture with Mobile Phone | Other | — | UNRESOLVED |
| Loop electrosurgical excision procedure (LEEP) | Procedure | — | UNRESOLVED |
| Pregnancy test | Diagnostic Test | — | UNRESOLVED |
| ScreenFire HPV test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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.
- interventionNames
- Diagnostic Test: HPV Test
- Device: EVA System
- Procedure: Visual Inspection with Acetic Acid (VIA)
- Diagnostic Test: Automated Visual Evaluation (AVE)
- Other: Image Capture with Mobile Phone
- Diagnostic Test: Pregnancy test
- Diagnostic Test: ScreenFire HPV test
- Procedure: Colposcopy with biopsy
- Procedure: Thermal Ablation
- Procedure: Loop electrosurgical excision procedure (LEEP)
Primary outcomes (2)
- measure
- Sensitivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 30 and 59 years of age Exclusion Criteria: * 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
References
Publications (9)
- BACKGROUNDRao DW, Bayer CJ, Liu G, Chikandiwa A, Sharma M, Hathaway CL, Tan N, Mugo N, Barnabas RV. Modelling cervical cancer elimination using single-visit screening and treatment strategies in the context of high HIV prevalence: estimates for KwaZulu-Natal, South Africa. J Int AIDS Soc. 2022 Oct;25(10):e26021. doi: 10.1002/jia2.26021. PMID 36225139
- BACKGROUNDParham GP, Egemen D, Befano B, Mwanahamuntu MH, Rodriguez AC, Antani S, Chisele S, Munalula MK, Kaunga F, Musonda F, Malyangu E, Shibemba AL, de Sanjose S, Schiffman M, Sahasrabuddhe VV. Validation in Zambia of a cervical screening strategy including HPV genotyping and artificial intelligence (AI)-based automated visual evaluation. Infect Agent Cancer. 2023 Oct 16;18(1):61. doi: 10.1186/s13027-023-00536-5. PMID 37845724
- BACKGROUNDHull R, Mbele M, Makhafola T, Hicks C, Wang SM, Reis RM, Mehrotra R, Mkhize-Kwitshana Z, Kibiki G, Bates DO, Dlamini Z. Cervical cancer in low and middle-income countries. Oncol Lett. 2020 Sep;20(3):2058-2074. doi: 10.3892/ol.2020.11754. Epub 2020 Jun 19. PMID 32782524
- BACKGROUNDDesai KT, Befano B, Xue Z, Kelly H, Campos NG, Egemen D, Gage JC, Rodriguez AC, Sahasrabuddhe V, Levitz D, Pearlman P, Jeronimo J, Antani S, Schiffman M, de Sanjose S. The development of "automated visual evaluation" for cervical cancer screening: The promise and challenges in adapting deep-learning for clinical testing: Interdisciplinary principles of automated visual evaluation in cervical screening. Int J Cancer. 2022 Mar 1;150(5):741-752. doi: 10.1002/ijc.33879. Epub 2021 Dec 6. PMID 34800038
- BACKGROUNDXue Z, Novetsky AP, Einstein MH, Marcus JZ, Befano B, Guo P, Demarco M, Wentzensen N, Long LR, Schiffman M, Antani S. A demonstration of automated visual evaluation of cervical images taken with a smartphone camera. Int J Cancer. 2020 Nov 1;147(9):2416-2423. doi: 10.1002/ijc.33029. Epub 2020 May 19. PMID 32356305
- BACKGROUNDEbrahimi N, Yousefi Z, Khosravi G, Malayeri FE, Golabi M, Askarzadeh M, Shams MH, Ghezelbash B, Eskandari N. Human papillomavirus vaccination in low- and middle-income countries: progression, barriers, and future prospective. Front Immunol. 2023 May 12;14:1150238. doi: 10.3389/fimmu.2023.1150238. eCollection 2023.