MedTrace Logo

HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid

NCT05385406 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5500

Last updated 2024-05-09

No results posted yet for this study

Summary

Cervical cancer is the leading cause of cancer death among women in sub-Saharan Africa, despite the existence of effective prevention and screening methods. Because vaccination rates against human papillomavirus (causing nearly all cervical cancers) are still insufficient in some low-resource countries, early detection and treatment of cervical lesions at risk of progressing to cancer are crucial components of cervical cancer control. Therefore, it is essential to find the most reliable and appropriate screening strategy in the context of low-resource countries in order to identify women in need of treatment and thus prevent the development of cervical cancer. The objective of our study is to compare two different methods of cervical cancer screening adapted to low-resource settings, in two study centers in Cameroon.

Conditions

Interventions

DIAGNOSTIC_TEST

HPV genotyping

Genotyping will be obtained by the Xpert system which uses 5 color channels containing primers and probes for the detection of specific genotypes or pooled results as follows: i) HPV 16, ii) HPV 18/45 in pooled result, iii) HPV types 31, 33, 35 52, or 58, in pooled result, iv) HPV types 51 or 59, in pooled result, and v) HPV types 39, 56, 66 or 68 in pooled result.

DIAGNOSTIC_TEST

Visual inspection after application of acetic acid

After application of acetic acid and Lugol's iodine, the cervix will be assessed using simplified "ABCD criteria" (A= acetowhite lesion within the transformation zone, B = spontaneous bleeding or upon slight touch, C (optional) = Lugol-positive coloring of acetowhite lesions, D = diameter \> 5mm of acetowhite lesion).

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • Bafoussam Regional Hospital, Cameroon

    collaborator UNKNOWN

  • Dschang District Hospital, Cameroon

    collaborator UNKNOWN

  • University of Dschang

    collaborator OTHER

  • Prof. Patrick Petignat

    lead OTHER

Principal Investigators

  • Patrick Petignat, PD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • Cameroon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385406 on ClinicalTrials.gov