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
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