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

NCT06042543 | Recruiting

• 2 other identifiers: IEC 22-32R37CA275824
• Study Type: interventional
• Target: 3,200
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Cervical Cancer; Screening

Outcome Measures

Primary Outcomes (1)

• Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)

  Participants with histologically confirmed cervical intraepithelial neoplasia grade 2, 3 or cancer, including CIN2 positive for p16.

  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

Study Arms (1)

Screening

EXPERIMENTAL

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.

Diagnostic Test: Screening with HPV test

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.

Screening

Eligibility Criteria

• Age: 25 Years - 49 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• No cervical screening during the previous 3 years
• Between the ages of 25 and 49 years
• Understands and signs a written informed consent form

You may not qualify if:

• Refusal to take part for any reason
• Actively menstruating or pregnant
• Treated earlier for cervical precancer or cancer

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of California, San Francisco: collaborator
• University of Zimbabwe: collaborator
• Lancaster University: collaborator
• Neo Sense Vector (NSV): collaborator
• International Agency for Research on Cancer: lead
• University of Cincinnati: collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

NOT YET RECRUITING

University of Zimbabwe

Harare, 0002, Zimbabwe

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Partha Basu, MD

  International Agency For Research On Cancer (IARC)

  PRINCIPAL INVESTIGATOR

• Bothwell Guzha, MD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

• Mike Chirenje Zvavahera, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ihtesham U Rehman, PhD

  Lancaster University

  PRINCIPAL INVESTIGATOR

• Walter Prendiville, MD

  Neo Sense Vector (NSV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Partha Basu, MD

CONTACT

+33764485370; basup@iarc.who.int

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: December 9, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

ZI (1); US (1)