Colposcopy referral rate can be reduced by high risk human papillomavirus (HPV) triage in the management of low-grade cytological lesions

ISRCTN	ISRCTN53680128
DOI	https://doi.org/10.1186/ISRCTN53680128
EudraCT/CTIS number	2010-022670-13
Secondary identifying numbers	2010-022670-13

Submission date: 27/08/2010
Registration date: 22/09/2010
Last edited: 22/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna-Maija Tapper
Scientific

BOX 140, 00290 HUS
Helsinki
00290
Finland

Study information

Study design	Randomised controlled three-arm trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (Finnish and Swedish only)
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
Study objectives	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(s)	The University of Helsinki Institutional Review Board approved on the 12th May 2005 (ref: 92/2005; 254/E9/05 [142/E8/05])
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2005
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	600
Key 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])
Key exclusion criteria	Previous known treatment for cervical intraepithelial neoplasia or cervical cancer
Date of first enrolment	01/05/2005
Date of final enrolment	31/05/2009

Locations

Countries of recruitment

Finland

Study participating centre

BOX 140, 00290 HUS

Helsinki
00290
Finland

Sponsor information

Helsinki University Hospital (Finland)
Hospital/treatment centre

BO 140
Helsinki
00290
Finland

Website	http://www.hus.fi/?path=59
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsinki University Hospital (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan