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RECRUITING
NCT05385406
NA

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

Sponsor: Prof. Patrick Petignat

View on ClinicalTrials.gov

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.

Official title: Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid: a Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

25 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

5500

Start Date

2022-12-06

Completion Date

2026-06-30

Last Updated

2024-05-09

Healthy Volunteers

Yes

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).

Locations (2)

Dschang Annex Regional Hospital

Dschang, Menoua, Cameroon

Bafoussam Regional Hospital

Bafoussam, Mifi, Cameroon