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AI-supported cervical cancer screening and treatment selection

This study is testing a new system that uses Artificial Intelligence (AI) to help screen for cervical cancer and decide on the best treatment. The AI system will analyze infrared signals from urine samples to detect high-risk Human Papillomavirus (hr-HPV), which can cause cervical cancer. You may be able to join if you are a woman between 25 and 49 years old, have not had cervical screening in the last three years, and have not been treated for cervical pre-cancer or cancer before. The study aims to see if this AI system can accurately identify cervical intraepithelial neoplasia grade 2 or worse (CIN2+), a pre-cancerous condition, over an average of 2 to 5 years.

Study design
This interventional study plans to enroll 3200 women. It involves screening with an HPV test and providing urine samples for AI analysis.
What's involved
You would be screened with an HPV test and provide urine samples. If HPV positive, you would be referred for a colposcopy (a procedure to examine the cervix).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 2 years from the start of recruitment, and then for an additional 3 years after the first part of the study is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06042543

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

Recruiting
NAAges 25–49InterventionalScreening
International Agency for Research on Cancer
~3,200 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Screening with HPV test

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
Measured over 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

Conditions

Cervical Cancer
Screening

Explore related trials

Cervical Carcinoma

Where it's being run

2 sites across 2 states
Ohio1
Zimbabwe1

Study leadership

  • Partha Basu, MD · PRINCIPAL_INVESTIGATOR · International Agency For Research On Cancer (IARC)
  • Bothwell Guzha, MD · PRINCIPAL_INVESTIGATOR · University of Zimbabwe
  • Mike Chirenje Zvavahera, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • Ihtesham U Rehman, PhD · PRINCIPAL_INVESTIGATOR · Lancaster University
  • Walter Prendiville, MD · PRINCIPAL_INVESTIGATOR · Neo Sense Vector (NSV)

Who to contact

Partha Basu, MD
[email protected]
+33764485370
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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

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