Plain English Summary
Background and study aims
Human papilloma viruses (HPV) are a family of viruses which affect the skin and moist membranes (mucosa) lining the body. HPVs are very common viruses, and will affect most people at some point in their lives. These viruses easily spread from person to person via skin-to-skin contact or contact during sex. There are over 100 different types of HPV, with more than 40 affecting the genital area. Some types of HPV, known as high risk types, have been linked to the development of abnormal cells in the cervix. If left untreated, this can greatly increase a woman’s risk of developing cervical cancer. Studies have shown that a large proportion of new cervical cancer cases are found in less developed countries. A possible reason for this is that women in these countries do not have access to vaccinations or a structured screening programme testing for the abnormal cells (Pap smear), due to high costs and a lack of trained healthcare professionals. Rapid HPV self-testing is where the woman herself is able to take a sample which can be tested. This has the advantage of being very inexpensive, and can reach a lot more women, especially in rural areas. The aim of this study is to test how practical and safe self-testing for HPV can be at preventing cervical cancer.
Who can participate?
Healthy women between 30 and 49 years old, with a good understanding of the HPV screening procedure
What does the study involve?
Women are given swabs so that they can take samples to be tested for HPV. Women who have a negative HPV test (absence of a HPV type that is linked to cervical cancer) are provided with reassurance and asked to repeat the test in 5 to 10 years. Women who have a positive HPV test (presence of a HPV type that is linked to cervical cancer) are invited for a visual inspection, where digital photographs of the cervix are taken and reviewed by experts. If the result is abnormal, then the women are offered therapy.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Dschang District Hospital (Cameroon)
When is the study starting and how long is it expected to run for?
June 2014 to August 2016
Who is funding the study?
1. Geneva University Hospitals (Switzerland)
2. National Fight Against Cancer Committee (France)
Who is the main contact?
Prof. Patrick Petignat
Trial website
Contact information
Type
Public
Primary contact
Prof Patrick Petignat
ORCID ID
http://orcid.org/0000-0002-6835-533X
Contact details
Boulevard de la Cluse 30
Geneva
1205
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15-068
Study information
Scientific title
Cervical cancer screening in Cameroon: feasibility of a single-visit approach using rapid HPV-testing
Acronym
Study hypothesis
Feasibility of a single-visit approach using rapid HPV-testing in low resource setting as Cameroon.
Ethics approval
1. Commission Cantonale d'Ethique de la Recherche (CCER) de Genève, 16/06/2015, ref: 15-068
2. National Ethics Committee for Human Health Research (Cameroon), 27/02/2015, ref: 2015/02/559/CE/CNERSH/SP
Study design
Prospective non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cervical cancer
Intervention
All women will take an HPV test. HPV-negative women will be reassured and counseled to repeat the test in 5 to 10 years. HPV-positive women with normal VIA/VILI test will undergo an endocervical curettage (ECC) and cytology to exclude presence of occult disease. HPV-positive women with abnormal VIA/VILI test will undergo a biopsy of abnormal area followed by therapy with cold coagulation. Pictures of the cervix and abnormal areas will be taken to assure a control of quality.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 26/09/2017:
The feasibility of HPV cervical cancer screen-and-treat approach in a low-resource context, assessed by measuring the number of women who took part in the screening campaign and the relative number of drop-outs and invalid test results at baseline
Previous primary outcome measures:
The prevalence of HPV infection and cervical pre-cancer and cancer will be determined among Cameroonian women at baseline, 6 months and 1 year
Secondary outcome measures
Current secondary outcome measures as of 26/09/2017:
1. The prevalence of HPV infection, cervical pre-cancer and cancer among Cameroonian women, determined using rapid HPV testing, cytology and histology at baseline
2. Performance of VIA/VILI and HPV16/18/45 genotyping for detection of high grade cervical lesions, determined using the kappa statistic at baseline
3. The association of risk factors leading to high-risk HPV infection and cervical pre-cancer and cancer, determined using calculated odds ratio (OR) at baseline
Previous secondary outcome measures:
1. To compare the agreement between histology and VIA results as well as cervical picture and VIA results, measured using the kappa statistic at 6 and 12 months
2. To evaluate the association of risk factors leading to high-risk HPV infection and promoting cervical neoplasia using calculated odds ratio (OR) at 6 months follow up
3. Verification as to whether HPV self-testing alone is an accurate test and can reduce the need for physician-cervical sampling, measured at 6 months follow up
4. HPV clearance is measured at 6 and 12 months
Overall trial start date
12/06/2014
Overall trial end date
31/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 30-49
2. Understanding of study procedures
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
1000
Participant exclusion criteria
1. Pregnancy
2. Previous hysterectomy
3. Conditions that can interfere with visualization of the cervix (menstruation)
4. Women who not able to comply with protocol study
Recruitment start date
08/07/2015
Recruitment end date
04/09/2015
Locations
Countries of recruitment
Cameroon
Trial participating centre
Dschang District Hospital
Dschang
-
Cameroon
Funders
Funder type
Hospital/treatment centre
Funder name
Geneva University Hospitals
Alternative name(s)
HUG
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Switzerland
Funder name
National Fight Against Cancer Committee
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
IPD sharing statement
The dataset is securely stored in the online database SecuTrial. As only the selected study investigators have access to it, the database will not be available to the public.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN99459678_BasicResults_19Sep17
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28580596
Publication citations
Additional files
- ISRCTN99459678_BasicResults_19Sep17.pdf Uploaded 19/10/2017