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Completed

NCT Number: NCT00479375

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect.

Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).

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Key information

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

32 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malmo University Hospital

Malmö, SE-20502, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 32-38 years old
  • Attending the Swedish population-based organised cervical screening program

Exclusion criteria

  • Not providing informed consent

Treatment and study plan

Adding Human Papillomavirus testing to organised cervical screening

Procedure

Primary outcomes

  1. Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up).

    Time frame: On average 4 years post baseline

Secondary outcomes

  1. Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints.

    Time frame: On average 4 years post baseline

  2. Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds

    Time frame: On average 7, 10, 13 (et cetera) years post base-line

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Europe Against Cancer (European Union Directorate General XII- Public Health)
  • Swedish Cancer Society

Registry information

Official study title

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Acronym: SWEDESCREEN

Important dates

Study start
1997
Study completion
2007
First posted
May 28, 2007
Registry last updated
May 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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