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NCT07232355 · ClinicalTrials.gov registry record

Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling

A clinical trial of Human Papilloma Virus, sponsored by Atila Biosystems.

Recruiting
Registry status
5,000
Enrollment target
4
Study locations

NCT07232355 is a study of Human Papilloma Virus that is actively recruiting participants, run by Atila Biosystems. The registered enrollment target is 5,000 participants, above the 432-participant average among 26 other Human Papilloma Virus trials with a reported enrollment target (1057% higher). The trial reports 4 study locations across 2 states.

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The verdict

NCT07232355, a study of Human Papilloma Virus, is actively recruiting participants, sponsored by Atila Biosystems.

RECRUITING
Registry status
5,000 participants
Enrollment target
4
Study locations

Study Summary

In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) countries until 2120 under existing conditions. Presently, more than 90% of worldwide cervical cancer cases occur in LMICs. To accelerate this timeline, there is an urgent need for accurate, affordable and rapid testing that can facilitate same-day screening-and-treatment of cervical precancer. The AmpFire® human papillomavirus (HPV) test (Atila Biosystems, CA) has the potential to meet these needs. The test has been adapted to classify HPV positive women into four categories according to their risk for cervical cancer development based on the specific HPV type found during the test. Moreover, results can be delivered in less than 20 minutes for the highest risk HPV type, and less than an hour for the remaining HPV types. This is a potential game changer for countries where treating all HPV positive women is unfeasible. A combination of HPV test with other image-based triage strategies can further reduce overtreatment while reaching the most at-risk women. The goal of this project is to evaluate the performance and feasibility of an innovative same-day screening-and-treatment strategy in Honduras based on the AmpFire® HPV test combined with imaging triage using artificial intelligence via the Automated Visual Evaluation (AVE). Additionally, the investigators will evaluate the cost-effectiveness of the proposed approach vs. the current strategy based on visual inspection with acetic acid (VIA). The investigators believe that the AmpFire® test will have the potential to detect at least 90% of women with cervical precancer (performance). Similarly, the investigators anticipate that combining AmpFire® with AVE triage in a same-day screening-and-treatment strategy will be feasible

Conditions Studied

Study Locations (4)

Other

  • Basic Health International - San Salvador
  • Centro de Salud Las Crucitas - Tegucigalpa
  • Ciudad Mujer Kennedy - Tegucigalpa

California

  • Atila Biosystems, Inc. - Sunnyvale

Trial Details

FieldValue
Enrollment Target 5,000 participants
Start Date 2023-08-24
Est. Completion 2026-06

Sponsor

Atila Biosystems

1 total trials

What the Registry Record Tells You About NCT07232355

The ClinicalTrials.gov registry entry for NCT07232355 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 432-participant average among 26 other Human Papilloma Virus trials with a reported enrollment target (1057% higher). The listed sponsor is Atila Biosystems, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Papilloma Virus appearing as the primary indexed condition, and to 0 interventions.

NCT07232355 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, California.

Frequently Asked Questions

What is clinical trial NCT07232355 about?

NCT07232355 is a clinical study titled "Prevention of Cervical Cancer Using the Genotyping Screening and Same-day Self-sampling". In May 2018, the World Health Organization (WHO) launched a strategy to eliminate cervical cancer. While this strategy seeks to achieve coverage of 70% in disease testing and 90% in treatment by 2030, it is estimated that these goals will not be achieved by most low- and middle- income (LMICs) count...

What is the current status of trial NCT07232355?

This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2023-08-24. Estimated completion is 2026-06.

What conditions does trial NCT07232355 study?

This clinical trial studies the following conditions: Human Papilloma Virus.

Who is sponsoring clinical trial NCT07232355?

This trial is sponsored by Atila Biosystems, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07232355 being conducted?

This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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