Condition category
Urological and Genital Diseases
Date applied
30/10/2017
Date assigned
19/12/2017
Last edited
05/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/01/2018: Internal review.