Cervical CancerNCT05385406
HPV Screening With Triage by HPV Genotyping Versus Visual Inspection With Acetic Acid
A study testing HPV genotyping and Visual inspection after application of acetic acid in people with Cervical Cancer, run by Prof. Patrick Petignat at 2 sites in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV genotyping and Visual inspection after application of acetic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,500 participants
- Where
- 2 sitesCameroon
- Study dates
- 6 Dec 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Pregnancy at the time of screening
- Previous hysterectomy
- Known cervical cancer
- Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- Conditions that can interfere with visualization of the cervix
- Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- Women who are not able to comply with the study protocol.
Trial locations and contacts
2 sites in 1 country.
Cameroon2 sites, 2 recruiting
- Not yet recruiting
Bafoussam Regional Hospital
Bafoussam, Mifi
Georges Enow Orock, Prof.
- Recruiting
Dschang Annex Regional Hospital
Dschang, Menoua
Bruno Kenfack, Pr, brunokenfack@gmail.com
About this study
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
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.
Read the detailed description
HPV used as a stand-alone test has a limited specificity and positive predictive value and as a consequence, a significant number of HPV-positive women have no cervical precancerous lesions or cancer and receive unnecessary workup and treatment. For this reason, the WHO has recommended visual inspection with acetic acid (VIA/VILI) as a triage test of HPV-positive women to identify women requiring treatment. Nevertheless, VIA is a highly subjective procedure dependent on the health care provider's experience, with diagnostic accuracy varying from setting to setting. Triage by HPV genotyping has recently emerged as an alternative to triage by VIA, with immediate treatment of women with a subset of high-risk HPV genotypes only, thus reducing overtreatment rates. However, to date, the triage of HPV-positive women by VIA versus HPV genotyping has not yet been compared. This project aims to implement primary HPV-based screening in Cameroon followed by an immediate offer for treatment by thermal ablation after randomization for triage by HPV genotyping or VIA. More specifically, we aim to determine if triage by HPV genotyping (with immediate treatment of women with HPV types 16, 18, 45, 31, 33, 35, 52 or 58) allows better targeting of women needing treatment and allocation of resources to women at-risk than triage by VIA, as recommended by the WHO.
Primary objective: To identify the most efficient screening strategy for cervical cancer in Cameroon, more specifically to determine whether triage by a pool of eight genotypes (HPV types 16, 18, 45, 31, 33, 35, 52 or 58) is more effective than triage by visual inspection with acetic acid for detection of precancerous lesions. ¨
Secondary objectives:
- To determine the overtreatment rate in each screening group (HPV genotyping and VIA/VILI)
- To determine the rate of adverse events (e.g. hemorrhage, infection, hospitalization) in each screening group
- To determine which participant characteristics may be associated with better prediction of CIN2+ for each screening group
- To assess patient and health care provider acceptability of both screening strategies
- To create a sustainable structure for the promotion of women health with a priority made in the prevention of cervical cancer West Region of Cameroon
- To treat all precancerous or cancerous lesions discovered during the screening
- To inform women and their families about gynecological pathologies, including cervical cancer, sexually transmitted diseases (STD) and HIV
- To create a database of cervical images for continuous clinical education
- To develop an Automated VIA/VILI Classifier (AVC) that can help identify cervical precancerous lesions based on a 2-minute video of the cervix during VIA/VILI
- To assess women's, the community's and healthcare providers' acceptability of the AVC test
Study Design: National multicentric open-label two-arm randomized controlled trial
Qualitative and quantitative studies for participants and health care providers will be included during the study period addressing preferences and attitudes toward the screening process and treatment.
- Conditions
- Cervical Cancer
- Being tested
- HPV genotyping, Visual inspection after application of acetic acid
- Keywords
- cervical cancer, human papillomavirus, screening, genotyping
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV genotypingDiagnostic test
Also called HPV GeneXpert
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 acidDiagnostic test
Also called VIA
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).
| Study group | Role | What they receive |
|---|---|---|
| Triage by genotyping | Experimental | The study intervention will consist in applying HPV genotyping as a triage method of HPV-positive women for cervical cancer screening. After primary screening with the Xpert HPV test, positive women will be sorted according to two groups of genotypes: group 1 (HPV types 16,18,45, 31, 33, 35, 52 and/or 58 obtained from channels 1, 2 and 3) and group 2 (HPV types 51, 59, 39,56, 66 and/or 68 obtained from channels 4 and 5). Women of group 1 will immediately treated, while those of group 2 will not receive immediate treatment and will be followed-up at 12 months. An exception will be made for participants with lesions suspicious of invasive cancer upon examination, which will be referred for further investigations regardless of the HPV type. Receives: Diagnostic Test: HPV genotyping |
| Triage by visual inspection after application of acetic acid (VIA) | Active comparator | The control arm will consist in triage of HPV-positive women by VIA, as currently recommended by the WHO. Women with a positive VIA will be treated immediately, while VIA-negative women will not be treated and will be followed-up at 12 months. Receives: Diagnostic Test: Visual inspection after application of acetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (9)
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.
Measured: 2 years
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.
Measured: 2 years
Overtreatment rate in each screening group
Overtreatment rate in each screening group, considered as treatment of participants with <CIN2 on histology
Measured: 2.5 years
Proportion of adverse events in each screening group
(e.g. hemorrhage, infection, hospitalization)
Measured: 2.5 years
Participant characteristics associated with better prediction of CIN2+ for each screening group
Odds ratios of correct prediction of CIN2+ for various participant characteristics in each screening group
Measured: 2 years
Estimated number of avoided cases of cervical cancer in each screening group
Estimated number of avoided cases of cervical cancer in each screening group based on identified and treated precancerous lesions and known rate of progression to cervical cancer if no treatment is provided.
Measured: 3 years
Patient and health care provider satisfaction with the screening process of each strategy
Satisfaction with the screening process in both study arms will be measured on a scale from 0 to 10 (on a paper survey) among participants at the end of the first visit, and by a qualitative analysis of data from focus group discussions and individual interviews with health care providers and patients, in order to assess acceptability of both strategies.
Measured: 2 years
Prevalence of HPV infection and cervical pre-cancer and cancer among Cameroonian women
Prevalence of HPV infection and cervical pre-cancer and cancer among Cameroonian women, based on HPV results obtained by self-sampling and analysis by the GeneXpert assay and on histological analyses of cervical biopsies and endocervical brushing.
Measured: 2 years
Number of cervical images captured by smartphone for clinical education
Creation of a database of anonymized cervical images for clinical education, captured by smartphone photography during the VIA/VILI process.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start6 Dec 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National multicentric open-label two-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Patrick Petignat
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Bafoussam Regional Hospital, Cameroon, Dschang District Hospital, Cameroon, University of Dschang
- Responsible party
- Sponsor-investigator, Prof. Patrick Petignat, University Hospital, Geneva
- Investigators
- Patrick Petignat, PD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385406
- Sponsor's protocol ID
- AO_2021-00066
- Status last verified
- May 2024
- First submitted
- 7 Dec 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data may be shared upon reasonable request at the end of the study period.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05385406
- Acronym / sponsor ID
- AO_2021-00066
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, human papillomavirus, screening, genotyping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Prof. Patrick PetignatUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Bafoussam Regional Hospital, Cameroon, Dschang District Hospital, Cameroon, University of Dschang
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HPV used as a stand-alone test has a limited specificity and positive predictive value and as a consequence, a significant number of HPV-positive women have no cervical precancerous lesions or cancer and receive unnecessary workup and treatment. For this reason, the WHO has recommended visual inspection with acetic acid (VIA/VILI) as a triage test of HPV-positive women to identify women requiring treatment. Nevertheless, VIA is a highly subjective procedure dependent on the health care provider's experience, with diagnostic accuracy varying from setting to setting. Triage by HPV genotyping has recently emerged as an alternative to triage by VIA, with immediate treatment of women with a subset of high-risk HPV genotypes only, thus reducing overtreatment rates. However, to date, the triage of HPV-positive women by VIA versus HPV genotyping has not yet been compared. This project aims to implement primary HPV-based screening in Cameroon followed by an immediate offer for treatment by thermal ablation after randomization for triage by HPV genotyping or VIA. More specifically, we aim to determine if triage by HPV genotyping (with immediate treatment of women with HPV types 16, 18, 45, 31, 33, 35, 52 or 58) allows better targeting of women needing treatment and allocation of resources to women at-risk than triage by VIA, as recommended by the WHO.
Primary objective: To identify the most efficient screening strategy for cervical cancer in Cameroon, more specifically to determine whether triage by a pool of eight genotypes (HPV types 16, 18, 45, 31, 33, 35, 52 or 58) is more effective than triage by visual inspection with acetic acid for detection of precancerous lesions. ¨
Secondary objectives:
- To determine the overtreatment rate in each screening group (HPV genotyping and VIA/VILI)
- To determine the rate of adverse events (e.g. hemorrhage, infection, hospitalization) in each screening group
- To determine which participant characteristics may be associated with better prediction of CIN2+ for each screening group
- To assess patient and health care provider acceptability of both screening strategies
- To create a sustainable structure for the promotion of women health with a priority made in the prevention of cervical cancer West Region of Cameroon
- To treat all precancerous or cancerous lesions discovered during the screening
- To inform women and their families about gynecological pathologies, including cervical cancer, sexually transmitted diseases (STD) and HIV
- To create a database of cervical images for continuous clinical education
- To develop an Automated VIA/VILI Classifier (AVC) that can help identify cervical precancerous lesions based on a 2-minute video of the cervix during VIA/VILI
- To assess women's, the community's and healthcare providers' acceptability of the AVC test
Study Design: National multicentric open-label two-arm randomized controlled trial
Qualitative and quantitative studies for participants and health care providers will be included during the study period addressing preferences and attitudes toward the screening process and treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- National multicentric open-label two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Triage by genotyping | Experimental | Diagnostic Test: HPV genotypingThe study intervention will consist in applying HPV genotyping as a triage method of HPV-positive women for cervical cancer screening. After primary screening with the Xpert HPV test, positive women will be sorted according to two groups of genotypes: group 1 (HPV types 16,18,45, 31, 33, 35, 52 and/or 58 obtained from channels 1, 2 and 3) and group 2 (HPV types 51, 59, 39,56, 66 and/or 68 obtained from channels 4 and 5). Women of group 1 will immediately treated, while those of group 2 will not receive immediate treatment and will be followed-up at 12 months. An exception will be made for participants with lesions suspicious of invasive cancer upon examination, which will be referred for further investigations regardless of the HPV type. |
| Triage by visual inspection after application of acetic acid (VIA) | Active comparator | Diagnostic Test: Visual inspection after application of acetic acidThe control arm will consist in triage of HPV-positive women by VIA, as currently recommended by the WHO. Women with a positive VIA will be treated immediately, while VIA-negative women will not be treated and will be followed-up at 12 months. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- Pregnancy at the time of screening
- Previous hysterectomy
- Known cervical cancer
- Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- Conditions that can interfere with visualization of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV genotypingAlso: HPV GeneXpertGenotyping 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 | Triage by genotyping |
| Visual inspection after application of acetic acidAlso: VIAAfter 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). | Diagnostic test | Triage by visual inspection after application of acetic acid (VIA) |
Primary outcome
Sensitivity of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) detection
Time frame: 2 years
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.
9 secondary outcomes
Specificity, positive predictive value and negative predictive value of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia
Time frame: 2 years
Percentage of participants who have correctly followed the screening, triage and treatment strategy in each study arm
Time frame: 2 years
Overtreatment rate in each screening group
Time frame: 2.5 years
Proportion of adverse events in each screening group
Time frame: 2.5 years
Participant characteristics associated with better prediction of CIN2+ for each screening group
Time frame: 2 years
Estimated number of avoided cases of cervical cancer in each screening group
Time frame: 3 years
Patient and health care provider satisfaction with the screening process of each strategy
Time frame: 2 years
Prevalence of HPV infection and cervical pre-cancer and cancer among Cameroonian women
Time frame: 2 years
Number of cervical images captured by smartphone for clinical education
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided. Anonymized data may be shared upon reasonable request at the end of the study period.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Petignat, PD principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV genotyping and Visual inspection after application of acetic acid in people with Cervical Cancer, run by Prof. Patrick Petignat at 2 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Petignat, PD (22 37 24 432 ext. +41, patrick.petignat@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of triage by HPV genotyping and VIA/VILI for cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) detection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.