Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
International Agency for Research on Cancer
Study ID
NCT06042543
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Screening with HPV test — DIAGNOSTIC_TEST
    Women aged 25-49 yrs will be screened with a validated HPV test. They will also provide urine samples for HPV test. Women HPV positive in either sample will be referred to colposcopy for disease ascertainment.

Study Details

Artificial intelligence (AI) is fast gaining reputation as a highly promising solution for cervical cancer screening. AI-based detection of cervical neoplasias is named automated visual exam (AVE) by the National Cancer Institute, USA. The investigators propose to develop and evaluate the performance characteristics of a novel AI system to both screen and triage women as well as help in treatment decision making. AI will analyse infrared spectroscopic signals derived from urine samples of unscreened women for the presence of high-risk human papillomavirus (hr-HPV). Our preliminary study has shown that spectroscopy can detect hr-HPV in urine. For screen-positive women the AI will interpret a set of cervical images captured with a high-quality devoted camera to detect high grade cervical precancers and cancers and to determine the type of transformation zone (TZ) (helps in treatment decision). The prototype device for image capture and the AI algorithms are already developed by us. The technologies will be further improved in part 1 (initial 2 years) and validated in part 2 (subsequent 3 years). During Part 1, the investigators will analyse urine samples collected from 1100 women at multiple screening clinics in Zimbabwe for the presence of hr-HPV using spectroscopy and use the signals generated to improve the AI algorithm. In this part the investigators will also assess the concordance between hr-HPV detection in urine samples using spectroscopy and cervical human papillomavirus (HPV) detection using a validated HPV test. The cervical image recognition device and the AI algorithm will be further improved during part 1 by collecting more images from hr-HPV positive and negative women. AI will also be trained to interpret the cervical images to determine the TZ type. In part 2 total 2100 women will be screened in Zimbabwe with AI-supported spectroscopic analysis of urine to detect hr-HPV and a validated HPV test to evaluate and compare their sensitivity and specificity to detect histology-proved high grade cervical precancers and cancers. The sensitivity and specificity of AI-supported detection of cervical neoplasias on cervical images will be evaluated to triage the HPV positive women. The accuracy of AI to determine TZ type will be compared with expert opinion. During the field validation part (part 2), the investigators will also conduct a cost analysis and compare cost of our approach to current standard Zimbabwean practice. The International Agency for Research on Cancer- World Health Organization WHO (IARC-WHO) has partnered with The Neo Sense Vector Company (NSV), Delaware, USA (industry), The Engineering Department, Lancaster University, Lancaster, UK and The University of Zimbabwe, College of Health Sciences, Harare, Zimbabwe to implement this study focusing on innovation that will greatly contribute to the global elimination of cervical cancer, a WHO priority.

Key Dates

Start date
Dec 9, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
3,200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Screening
    The EASTER project aims to further develop and validate two new technologies for cervical cancer screening and diagnosis: (i) screening for human papillomavirus (HPV) in urine with spectroscopy, and (ii) diagnosis with artificial intelligence-assisted technology from the Neo Sense Vector Company (NSV), a private company. The project will recruit 3200 women and screen them for HPV.

Primary Outcome Measure

Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) [ Time Frame: a) Through completion of part 1, an average of 2 years from the start of recruitment; b) Through completion of part 2, an average of 3 years after completion of part 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45221
Leeya Pinder, MD
[email protected]

Find similar trials in Cincinnati, OH

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Cincinnati· Cincinnati, OH

Related Studies