Health Trials

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

ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorProf. Patrick Petignat

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

HIV-negative women aged 30-49 and HIV-positive women aged 25-49 years old

Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).

Disqualifiers

Pregnancy at the time of screening

Previous hysterectomy

Known cervical cancer

Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)

Trial design

Design model

Parallel

Treatments tested in this trial

  • HPV genotyping

    Diagnostic test

    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.

  • Visual inspection after application of acetic acid

    Diagnostic test

    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).

Treatment groups

5,500 Participants
are divided into 2 treatment groups
Group A: Triage by genotypingExperimental treatment 1 intervention
Group B: Triage by visual inspection after application of acetic acid (VIA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) detection

Sensitivity of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) detection at time of screening (first visit), considering histologic results (from cervical biopsy and/or endocervical brushing) as the gold-standard.

Time frame
2 years

Secondary outcomes

1

Specificity, positive predictive value and negative predictive value of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia

Specificity, PPV and NPV of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) detection at time of screening (first visit), considering histologic results as the gold-standard.

Time frame
2 years
2

Percentage of participants who have correctly followed the screening, triage and treatment strategy in each study arm

The percentage of participants who have correctly followed the screening, triage and treatment strategy in each study arm will be measured to assess the feasibility of both triage strategies. This will be measured by study case report forms for both arms.

Time frame
2 years
3

Overtreatment rate in each screening group

Overtreatment rate in each screening group, considered as treatment of participants with \<CIN2 on histology

Time frame
2.5 years
4

Proportion of adverse events in each screening group

(e.g. hemorrhage, infection, hospitalization)

Time frame
2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Patrick Petignat

Lead sponsor

University Hospital, Geneva

Sponsor institution

University Hospital, Geneva

Collaborator

Bafoussam Regional Hospital, Cameroon

Collaborator

Dschang District Hospital, Cameroon

Collaborator

University of Dschang

Collaborator

Source ClinicalTrials.gov
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