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

Human Papilloma Virus (HPV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709891
• Other study ID #: RD000649
• Secondary ID: MWP-HPV-159
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: February 5, 2015
• Start date: May 2008
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47208
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Human Papilloma Virus (HPV)
• Uterine Cervical Diseases

Intervention

Device:
• cobas® 4800 HPV Test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Diagnosis of = CIN2	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.	Baseline to the end of the Baseline period (up to 12 weeks)	No
Secondary	Percentage of Participants With a Diagnosis of = CIN3	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.	Baseline to the end of the study (up to 5 years, 1 month)	No