An interventional study of HPV genotyping and Visual inspection after application of acetic acid in Cervical Cancer, sponsored by Prof. Patrick Petignat. Recruiting at 2 sites in Cameroon. Open to female participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Prof. Patrick Petignat · Not applicable, Interventional, and Diagnostic
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.
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:
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 5,500 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Prof. Patrick Petignat is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: HPV genotyping
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.
Diagnostic Test: Visual inspection after application of acetic acid
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.
Also known as: HPV GeneXpert
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).
Also known as: VIA
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
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
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
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
Proportion of adverse events in each screening group
(e.g. hemorrhage, infection, hospitalization)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 years
Plan to share: Undecided — Anonymized data may be shared upon reasonable request at the end of the study period.
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Prof. Patrick Petignat