Condition category
Urological and Genital Diseases
Date applied
10/10/2013
Date assigned
08/11/2013
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Human papillomavirus (HPV) causes changes in the cells lining the cervix (cervical epithelial cells), which usually are detected by cytological testing (Pap smear). Most sexually active individuals will acquire an HPV infection during their lifetime. The majority of these HPV infections clear spontaneously especially among young women, but a prolonged infection can lead to precancerous lesions of the cervix (Cervical Intraepithelial Neoplasia, CIN) or even to cervical cancer.
CIN can be treated by a loop electrosurgical excision procedure (LEEP) in an outpatient setting with local anesthesia. Previous studies have shown that LEEP can cause preterm delivery in subsequent pregnancies. LEEP, as with all surgical procedures, can also cause acute complications such as hemorrhage or infection. Because of these risks LEEPs should be avoided if possible, especially in young patients. In Finland updated treatment guidelines for CIN1 (CIN grade 1) suggest a two-year follow-up instead of immediate treatment for all patients. The most recent update of American treatment guidelines for CIN suggest a two-year follow-up for young patients with moderate CIN (CIN2), because in previous studies up to 68 % of these lesions have been found to clear spontaneously.
Currently it cannot be determined which CIN will go away spontaneously (regression) and which will progress. Genetic regulatory factors have been thought to have an impact on the process. This genetic regulation can be studied from tissue samples.
We will perform a study in which we will follow-up women aged 18 to 30 years with CIN2 instead of immediate LEEP treatment. We will look at factors associated with the regression or progression of the lesion (for example birth control method used, pregnancies) and use tissue samples to study the genetic regulatory factors.

Who can participate?
We are recruiting patients being treated at Helsinki University Central Hospital’s women’s clinic who are between 18 and 30 years of age and diagnosed with CIN2.

What does the study involve?
Patients in the study will be followed-up at the colposcopy clinic every six months up to two years. A detailed patient history will be collected with a questionnaire. Every visit will include a colposcopy (a procedure in which the surface of the cervix is closely examined using a magnifying instrument called a colposcope) and cervical biopsies (a medical procedure that involves taking a small sample of tissue so that it can be examined under a microscope) will be taken when needed. Most visits will also include a cytological sample and a test for HPV genotyping. If the lesion has completely regressed (cleared) at the one-year visit, the next follow-up will be at two years from the beginning of the study. If the lesion has not regressed in two years it will be treated with LEEP. It will also be performed if the patient wishes to leave the study or the lesion has progressed. After the study period follow-up will continue as normal.

What are the possible benefits and risks of participating?
Possible benefits include avoiding unnecessary surgical treatment. The risk for progression of the lesion is considered to be low due to the careful follow-up program.

Where is the study run from?
The study is run and performed at the women’s clinic of Helsinki University Central Hospital (HUCH), Finland.

When is the study starting and how long is it expected to run for?
The study is recruiting patients between October 2013 and September 2016.

Who is funding the study?
The study is funded by Helsinki University Central Hospital (HUCH), Finland.

Who is the main contact?
Dr Maija Jakobsson
maija.jakobsson@hus.fi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pekka Nieminen

ORCID ID

Contact details

Women's clinic
BO 610
Helsinki
00290
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Untreated CIN2 follow-up study of young patients

Acronym

Study hypothesis

In our study we will follow-up 18-30-year-old women with biopsy-confirmed CIN2 at six-month intervals for up to 24 months. The aim is to assess follow-up as an option for immediate surgical treatment in young patients who may suffer from the possible long-term consequences of loop electrosurgical excision procedure (LEEP).

Ethics approval

University of Helsinki Institutional Review Board; 24/04/2013; ref: 131/13/03/03/2013

Study design

Observational single-centre study

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Finnish and English)

Condition

Cervical Intraepithelial Neoplasia, grade 2

Intervention

At baseline:
1. Patient information, written consent
2. Colposcopy
3. Sample for HPV genotyping

At 6 months:
1. Colposcopy
2. Cytology
3. Punch biopsy/biopsies for methylation studies and according to clinician's judgement

At 12 months:
1. Colposcopy
2. Cytology
3. Sample for HPV genotyping
4. Punch biopsy/biopsies according to clinician's judgement

At 18 months:
1. Colposcopy
2. Cytology
3. Punch biopsy/biopsies according to clinician's judgement

At 24 months:
1. Colposcopy
2. Cytology
3. Sample for HPV genotyping
4. At least two punch biopsies

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Histological regression to normal at 24 months follow-up

Secondary outcome measures

1. Histological regression to ≤CIN1 at 24 months
2. Histological progression to > CIN2
3. HPV negativity at 24 months

Overall trial start date

14/10/2013

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 to 30 years at first study visit
2. Biopsy-confirmed diagnosis of CIN2

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 300

Participant exclusion criteria

1. Cervical cancer
2. High-grade CIN (CIN3), high-grade vulvar or vaginal dysplasia (VIN 3, VAIN 3)
3. Previous LEEP of CIN3
4. A very large or not completely visible CIN2 lesion in colposcopy
5. Pregnancy or breastfeeding
6. Human immunodeficiency virus (HIV)-positive
7. Immunosuppressive medication
8. Language difficulties (patients who do not speak sufficient Finnish or English)

Recruitment start date

14/10/2013

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Finland

Trial participating centre

Women's clinic
Helsinki
00290
Finland

Sponsor information

Organisation

Helsinki University Central Hospital (Finland)

Sponsor details

c/o Dr. Pekka Nieminen
Women's clinic
BO 610
Helsinki
00290
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University Central Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes