Results Comparison of Cervical Cancer Early Detection Usi... | NCT06518070

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

NCT06518070

Sponsor

Universitas Padjadjaran

Status

Completed

Last Update Posted

Jul 24, 2024Actual

Enrollment

44Actual

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Cerviray AI

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Jun 1, 2024

First Submission Date that Met QC Criteria

Jul 20, 2024

First Posted Date

Jul 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cerviray AI	Diagnostic Test	Patient was screened using Cerviray AI, Cerviray AI evaluation by expert anc compared to VIA test in the same day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerviray AI	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.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Cancer cervix is only limited in female patient

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

women of childbearing age who would be screened for cervical cancer in West Java Province

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Padjajaran University		Bandung			Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39844244	Derived	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.

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site