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OpenTrials
Completed

NCT Number: NCT06518070

Results Comparison of Cervical Cancer Early Detection Using Cerviray With VIA Test

Cervical cancer, primarily caused by Human Papilloma Virus (HPV), is a significant global health concern, ranking as the fourth most common cancer in women worldwide. In Indonesia, it stands as the second most frequent cancer among women. This study investigates the performance of Cerviray® AI and Cerviray® AI Evaluation, an artificial intelligence (AI) technology for diagnosing cervical cancer, aiming to compare its sensitivity, specificity, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC ROC) with the Visual Inspection with Acetic Acid (VIA) test.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Padjajaran University

Bandung, Indonesia

About this study

The study involved 44 patients from various health centers in West Java Province. Cerviray® AI, Cerviray® AI Evaluation, and VIA tests were administered to high-risk women of childbearing age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • high-risk women of childbearing age who would be screened for cervical cancer (by Cerviray AI examination, Cerviray AI evaluation, and VIA test) at 1 clinic and other 4 health centers

Exclusion criteria

  • incomplete data
  • patient refusing to be examined
  • patient refusing to participate in the study

Treatment and study plan

Cerviray AI

Diagnostic Test

Patient was screened using Cerviray AI, Cerviray AI evaluation by expert anc compared to VIA test in the same day.

Primary outcomes

  1. Cerviray AI

    Time frame: 1 day

    The target population screened using Cerviray AI tools and Cerviray AI evaluation and will be compared to VIA test and confirmed by the anatomical pathology examination. The data will be shown as analytical results of the Cerviray AI tool.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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