Condition category
Cancer
Date applied
27/08/2010
Date assigned
22/09/2010
Last edited
22/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna-Maija Tapper

ORCID ID

Contact details

BOX 140
00290 HUS
Helsinki
00290
Finland

Additional identifiers

EudraCT number

2010-022670-13

ClinicalTrials.gov number

Protocol/serial number

2010-022670-13

Study information

Scientific title

Colposcopy referral rate can be reduced by high risk human papillomavirus (HPV) triage in the management of low-grade cytological lesions: a randomised controlled 3-arm trial

Acronym

Study hypothesis

To study if colposcopy referrals can be reduced by using repeated pap smear in combination with high risk human papillomavirus (HPV) test in management of low-grade cytological lesions. Hypothesising that a considerable proportion of cervical lesions heal spontaneously we also studied the possibility to perform colposcopy in delayed schedule.

Ethics approval

The University of Helsinki Institutional Review Board approved on the 12th May 2005 (ref: 92/2005; 254/E9/05 [142/E8/05])

Study design

Randomised controlled three-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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 Swedish only)

Condition

Cervical intraepithelial neoplasia (CIN)

Intervention

Group A: colposcopy with punch biopsy, pap smear and hrHPV test within 2 - 3 months from referral pap smear.
Group B: same procedures were performed with delayed schedule, within 6 months from referral.
Group C: repeat pap smear and hrHPV test were performed first and colposcopy was offered to only women who were either hrHPV positive, or to those hrHPV negative women who had pap smear LSIL or worse. If women were diagnosed with CIN 2 or worse, she was treated with LLETZ. Also CIN1 lesions were treated with LLETZ among women older than 30 years.

All women had pap smear and hrHPV test in 6 - 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of hrHPV positives in different study groups
2. Number of high-grade CIN

Assessed at primary colposcopy (Group A at 2 - 3 months from referral pap smear, Group B within 6 months from referral pap smear and Group C at primary colposcopy, within 6 months from referral pap smear) among those women who had colposcopy. Also followed up with pap smear and hrHPV at 6 - 12 months from primary colposcopy visit.

Secondary outcome measures

Number of low-grade CIN (CIN1).

Assessed at primary colposcopy (Group A at 2 - 3 months from referral pap smear, Group B within 6 months from referral pap smear and Group C at primary colposcopy, within 6 months from referral pap smear) among those women who had colposcopy. Also followed up with pap smear and hrHPV at 6 - 12 months from primary colposcopy visit.

Overall trial start date

01/05/2005

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients aged 16 - 72 years
2. Referred to colposcopy because of low-grade pap smear abnormality (repeated atypical squamous cells of undetermined significance [ASCUS] or low-grade squamous intraepithelial lesion [LSIL])

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant exclusion criteria

Previous known treatment for cervical intraepithelial neoplasia or cervical cancer

Recruitment start date

01/05/2005

Recruitment end date

31/05/2009

Locations

Countries of recruitment

Finland

Trial participating centre

BOX 140, 00290 HUS
Helsinki
00290
Finland

Sponsor information

Organisation

Helsinki University Hospital (Finland)

Sponsor details

BO 140
Helsinki
00290
Finland

Sponsor type

Hospital/treatment centre

Website

http://www.hus.fi/?path=59

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University 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