NCT06042543 Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs
| NCT ID | NCT06042543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Agency for Research on Cancer |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2023-12-09 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,200 participants in total. It began in 2023-12-09 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Refusal to take part for any reason * Actively menstruating or pregnant * Treated earlier for cervical precancer or cancer
Contact & Investigator
Partha Basu, MD
PRINCIPAL INVESTIGATOR
International Agency For Research On Cancer (IARC)
Frequently Asked Questions
Who can join the NCT06042543 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 49 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06042543 currently recruiting?
Yes, NCT06042543 is actively recruiting participants. Contact the research team at basup@iarc.who.int for enrollment information.
Where is the NCT06042543 trial being conducted?
This trial is being conducted at Cincinnati, United States, Harare, Zimbabwe.
Who is sponsoring the NCT06042543 clinical trial?
NCT06042543 is sponsored by International Agency for Research on Cancer. The principal investigator is Partha Basu, MD at International Agency For Research On Cancer (IARC). The trial plans to enroll 3,200 participants.
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