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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53680128

Enrollment

600

Registered

2010-09-22

Start date

2005-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia (CIN) Cancer In situ neoplasms

Interventions

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 referra

Eligibility

Sex/Gender

Female

Inclusion criteria

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])

Exclusion criteria

Exclusion criteria: Previous known treatment for cervical intraepithelial neoplasia or cervical cancer

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026