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NCT06042543 · ClinicalTrials.gov registry record · NA
Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs
A NA study of Cervical Cancer and Screening, sponsored by International Agency for Research on Cancer.
- Recruiting
- Registry status
- NA
- Development phase
- 3,200
- Enrollment target
- 2
- Study locations
NCT06042543: Recruiting NA study of Cervical Cancer and Screening, sponsored by International Agency for Research on Cancer.
NCT06042543 is a NA study of Cervical Cancer and Screening that is actively recruiting participants, run by International Agency for Research on Cancer. The registered enrollment target is 3,200 participants, above the 548-participant average among 144 other Cervical Cancer trials with a reported enrollment target (484% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06042543, a NA study of Cervical Cancer and Screening, is actively recruiting participants, sponsored by International Agency for Research on Cancer.
- RECRUITING
- Registry status
- NA
- Development phase
- 3,200 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
Participants with histologically confirmed cervical intraepithelial neoplasia grade 2, 3 or cancer, including CIN2 positive for p16.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Screening with HPV test
Study Locations (2)
Ohio
- University of Cincinnati - Cincinnati
Other
- University of Zimbabwe - Harare
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,200 participants |
| Start Date | 2023-12-09 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT06042543 shows while recruiting
NCT06042543 is an interventional study that assigns participants to a tested intervention. Its 3,200 participants enrollment target places it among the larger protocols in the corpus, above the 548-participant average among 144 other Cervical Cancer trials with a reported enrollment target (484% higher).
The record links to 2 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 1 intervention - of which Screening with HPV test is the first listed.
NCT06042543 reports a single indexed study location in Ohio, Other.
Frequently Asked Questions
What is clinical trial NCT06042543 about?
NCT06042543 is a clinical study titled "Novel, One Stop, Affordable, Point of Care and AI Supported System of Screening, Triage and Treatment Selection for Cervical Cancer in LMICs". 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 performanc...
What is the current status of trial NCT06042543?
This trial is currently recruiting. It is a NA study. The enrollment target is 3,200 participants. The study started on 2023-12-09. Estimated completion is 2027-12-31.
What conditions does trial NCT06042543 study?
This clinical trial studies the following conditions: Cervical Cancer, Screening.
What interventions are being tested in trial NCT06042543?
The interventions under investigation include: Screening with HPV test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06042543?
This trial is sponsored by International Agency for Research on Cancer, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06042543 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06042543's enrollment target sits among peer trials
3,200 6th of 144 higher than 139 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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