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Completed

NCT Number: NCT00709891

Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease

This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.

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Key information

Conditions

Human Papilloma Virus (HPV)

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Enterprise, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females ≥ 21 years of age presenting for routine cervical cancer screening.
  • An intact cervix.
  • Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.

Exclusion criteria

  • Known pregnancy at study Visit 1.
  • Presenting for colposcopy at study Visit 1.
  • Any condition resulting in increased risk of bleeding at biopsy.
  • Hysterectomy.
  • Known history of ablative or excisional therapy to the cervix within the preceding 12 months.

Treatment and study plan

cobas® 4800 HPV Test

Device

Primary outcomes

  1. Percentage of Participants With a Diagnosis of ≥ CIN2

    Time frame: Baseline to the end of the Baseline period (up to 12 weeks)

    A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.

Secondary outcomes

  1. Percentage of Participants With a Diagnosis of ≥ CIN3

    Time frame: Baseline to the end of the study (up to 5 years, 1 month)

    A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 3, 2008
Registry last updated
Feb 9, 2015

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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