Plain English Summary
Background and study aims
Human papillomavirus (HPV) causes infections of the cervix in women, which can lead to cancer precursor lesions and, if untreated, cervical cancer. There are approximately over 200 types of HPV known to date, some presenting a higher risk for developing precancerous disease. HPV infections are very common as nearly all sexually active individuals get infected during their lifetime and many of these infections are cleared without treatment. HPV related changes in the cervix can be detected by Pap smears (a test that collects cells from the cervix). After an abnormal Pap smear result the cervix can be examined with colposcopy and punch biopsies can be taken to determine the best course of action. If a moderate or severe lesion is diagnosed in the cervix the most common treatment is LLETZ (large loop excision of the transformation zone). LLETZ has a good cure rate for cancer precursors, but it has been associated with increased risk of preterm delivery in subsequent pregnancies. The exact reason underlying this is still unknown and even women with mild lesion that have regressed during active surveillance without any treatment have shown a slightly increased risk for preterm delivery. The aim of this study is to assess the risk for preterm delivery after colposcopy and/or cervical treatment as well as assess the prevalence, clearance and incidence of new HPV genotype infections within two years of recruitment. It also aims to assess the sensitivity and specificity of the colposcopic examination and the rates and risk factors for complications of colposcopy or treatments.
Who can participate?
Women aged 18 and older who are referred to have a colposcopy.
What does the study involve?
Participants receive a colposcopy as done to the standard level of care. At the start of the study, participants fill out a detailed questionnaire about their general health, sexual habits and history. During colposcopy visits up to two years from recruitment an extra cervical brush sample is taken. Data is taken from participant’s hospital records and national health registries until death or if they move out of the country.
What are the possible benefits and risks of participating?
Participants may benefit from the possibility to get extra information on the HPV genotype(s) behind the condition being treated/followed-up, in usual clinical practice we commonly only test for the presence of high-risk HPV viruses. There is no risk in participating in the trial as treatment and follow-up is done according to current treatment guidelines.
Where is the study run from?
Helsinki University Hospital, Womens' Clinic (UK)
When is the study starting and how long is it expected to run for?
January 2014 to December 2050
Who is funding the study?
Helsinki University Central Hospital (Finland)
Who is the main contact?
Professor Pekka Nieminen
pekka.nieminen@hus.fi
Trial website
Contact information
Type
Public
Primary contact
Prof Pekka Nieminen
ORCID ID
Contact details
University of Helsinki and Helsinki University Hospital
Haartmaninkatu 2
Helsinki
00290
Finland
+358 94711
pekka.nieminen@hus.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Helsinki colposcopy and preterm birth cohort study
Acronym
HELICOPTER
Study hypothesis
Treatment of the cervix for cancer precursors has been shown to increase the risk for preterm delivery in retrospective data.
Ethics approval
Helsinki University Hospital District, 24/04/2013, ref: 130/13/03/03/2013
Study design
Observational longitudinal cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Gynaecological HPV related diseases where patients have been referred to colposcopy.
Intervention
Participants in this trial are treated according to current treatment guidelines and followed at the colposcopy clinic accordingly. At enrolment participants fill in a detailed questionnaire on their general health, sexual habits and history. At each follow-up visit until two years after enrolment an extra cervical sample is obtained. Data on participants is extracted from hospital records and national health registries. The first observation period for the participants is up to two years. Hospital and national records may be re-reviewed until the participants death or moving out of the country.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Incidence of preterm birth after colposcopy and/or cervical treatment is measured using the information in hospital records and national health registries at five, seven and ten years after enrollment.
Secondary outcome measures
1. Prevalence, clearance, and incidence of new HPV infections is measured with the extra cervical brush samples (HPV genotyping) obtained at any visit at the colposcopy clinic up to two years after enrolment
2. Sensitivity and specificity of colposcopic evaluation is measured using data from hospital records up to two years after enrolment
3. Rate of complications of colposcopy and treatment and risk factors are measured using using data from hospital records up to two years after enrolment
Overall trial start date
01/01/2014
Overall trial end date
31/12/2050
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Any woman 18 years of age or older
2. Referred to colposcopy at Helsinki University Hospital
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1000
Participant exclusion criteria
Under the age of 18
Recruitment start date
13/01/2014
Recruitment end date
13/05/2016
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Hospital, Womens' Clinic
Haartmaninkatu 2
Helsinki
00290
Finland
Sponsor information
Organisation
University of Helsinki and Helsinki University Hospital
Sponsor details
Haartmaninkatu 2
Helsinki
00290
Finland
+359 4711
pekka.nieminen@hus.fi
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Helsingin ja Uudenmaan Sairaanhoitopiiri
Alternative name(s)
Helsinki University Central Hospital, HUS
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Finland
Results and Publications
Publication and dissemination plan
The results for prevalent HPV genotype infections and associations will be published in the near future. Results for HPV genotype specific clearance and incidence of new infections will be published in 2019. Sensitivity and specificity of colposcopy and complication rates will be published in 2018. Results for the main outcome measure can be anticipated within 10-15 years from the trial start.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/03/2018
Participant level data
Other
Basic results (scientific)
Publication list