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

NCT ID: NCT06518070

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Cerviray AI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Padjajaran University

Bandung, , Indonesia

Site Status

Countries

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Indonesia

References

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Harsono AB, Susiarno H, Suardi D, Mantilidewi KI, Wibowo VD, Hidayat YM. Results comparison of cervical cancer early detection using cerviray (R) with VIA test. BMC Res Notes. 2025 Jan 22;18(1):30. doi: 10.1186/s13104-025-07086-6.

Reference Type DERIVED
PMID: 39844244 (View on PubMed)

Other Identifiers

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OBGY-202405.01

Identifier Type: -

Identifier Source: org_study_id

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