Condition category
Infections and Infestations
Date applied
15/09/2015
Date assigned
22/03/2016
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Human papilloma virus (HPV) are common viruses that affect the skin and moist membranes lining parts of the body, for example, the mouth, cervix and vagina. Most people will be infected with HPV at some point in their lives. It rarely causes any problems and goes away on its own. Some HPVs can cause changes to the cells of the cervix. These changed cells are then more likely to become cancerous. HPV infection is a necessary, but not sufficient cause for the development of cervical cancer and its precursors (that is, pre-cancerous changes).Our knowledge about human microbiome (the microorganisms – such as bacteria and viruses - on and in our body) has increased vastly after the development of novel sequencing methods and only recently HPV clearance rate (i.e how long it takes for the infection to go away) was shown to be dependent on vaginal microbiome type. Since development of cervical cancer requires HPV infection, studying the interplay between vaginal microbiome, mucosal immune system (the part of the immune system that protects mucous membranes) , HPV status (state of infection, if any), and the clinical presentation of the disease simultaneously is crucial for understanding why only a fraction of women infected with HPV develop cervical cancer. The aim of this study is to investigate whether the removal of abnormal (mucus secreting) cells during LEEP (loop electrosurgical excision procedure) treatment affects the immune defence system of the cervix, leading to an inbalance in the normal vaginal microbiome (dysbiosis) and possibly increasing the likelihood of inflammation and prolonged HPV infection.

Who can participate?
Women aged between 18-45, not pregnant and have been referred to colposcopy (a procedure to check for abnormal cells in a womans cervix or vagina) due to an abnormal Pap smear result.

What does the study involve?
Participants are placed into one of three groups. Those in group 1 are referred to colposcopy and LEEP treatment. Those in group 2 are referred to colposcopy, but do not have lesions (pre-cancerous changes) requiring LEEP treatment. Those in group 3 (the control group) have been recruited during routine Pap smear screening. Samples are taken from all participants before colposcopy and then six months later.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Helsinki University Central Hospital (HUCH) Womens Hospital

When is the study starting and how long is it expected to run for?
September 2015 to December 2020

Who is funding the study?
Helsinki University Central Hospital

Who is the main contact?
Dr Pekka Nieminen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pekka Nieminen

ORCID ID

Contact details

Kätilöopiston Sairaala
Sofianlehdonkatu 5 A
Helsinki
00029 HUS
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The association between preterm birth, vaginal microbiome, immune defence and HPV among women with cervical precancer: an observational single-center study

Acronym

MI-HPV

Study hypothesis

Our hypothesis is that the removal of mucus secreting cells in LEEP treatment compromises cervical immune defense and thus predisposes to ascending infection or inflammatory response against normal flora altering microbiota in the vagina and the microbiota might be dysbiotic in the first place to allow prolonged HPV-infection.

Ethics approval

University of Helsinki Institutional Review Board, 30/01/2014, ref: 21/13/03/2014

Study design

Observational single-center study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

HPV infection

Intervention

We will recruit women referred to colposcopy due to an abnormal Pap smear result, age 18 to 45, who are not pregnant and have no previous cervical operation. There are then allocated to one of three groups.
1. Main study group: Women referred to colposcopy and LEEP treatment
2. Control group 1: Women referred to colposcopy, but do not have lesions requiring LEEP treatment.
3. Control group 2: Women recruited during routine Pap smear screening at HUSLab

Samples are taken before colposcopy and after six months follow-up, during the first control visit.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Presence of immunomarkers, using multiplex ELISA
2. HPV-status, using PCR
3. Analysis of microbiota, by measuring hypervariable 16S

Results are compared between patients receiving treatment for HPV lesions with those that do not require treatment for lesions. Measurements are taken at baseline and 6 months later.

Secondary outcome measures

1. Presence of immunomarkers
2. HPV-status
3. Analysis of microbiota

Results are compared between patients with HPV at a colposcopy clinic to "healthy" controls undergoing Pap screening. Measurements are taken at baseline and 6 months later.

Overall trial start date

17/09/2015

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers and colposcopy patients.

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

50+50+50

Participant exclusion criteria

1. Pregnancy
2. Vaginal bleeding
3. Previous cervical surgery

Recruitment start date

17/09/2015

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Central Hospital (HUCH) Womens Hospital
Helsinki
00610
Finland

Sponsor information

Organisation

Helsinki University Central Hospital

Sponsor details

Kätilöopiston Sairaala
Sofianlehdonkatu 5 A
Helsinki
00029 HUS
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi

Funders

Funder type

Not defined

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

Funder name

Helsingin Yliopisto

Alternative name(s)

University of Helsinki, Helsingfors Universitet

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Finland

Results and Publications

Publication and dissemination plan

1. Planned methods publication 2016-2017.
2. Planned other publications 2017-2019.

Intention to publish date

01/01/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes