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 |
| Clinical Trials Information System (CTIS) | 2010-022670-13 |
| Protocol serial number | 2010-022670-13 |
| Sponsor | Helsinki University Hospital (Finland) |
| Funder | Helsinki University Hospital (Finland) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
BOX 140, 00290 HUS
Helsinki
00290
Finland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled three-arm trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
1. Number of hrHPV positives in different study groups |
| Key secondary outcome measure(s) |
Number of low-grade CIN (CIN1). |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
00290
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
