N/A N=47,208 Triple-blind Diagnostic

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

Human Papilloma Virus (HPV)

Bottom Line

View on ClinicalTrials.gov: NCT00709891 ↗

Enrolled (actual)

47,208

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Percentage of Participants With a Diagnosis of ≥ CIN2 — 14.0; 0.8 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: cobas® 4800 HPV Test (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Hoffmann-La Roche
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Diagnosis of ≥ CIN2	14.0; 0.8	—
SECONDARY Percentage of Participants With a Diagnosis of ≥ CIN3	8.4; 0.3	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00709891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.