Trial Outcomes & Findings for Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease (NCT NCT00709891)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47208 participants

Primary outcome timeframe

Baseline to the end of the Baseline period (up to 12 weeks)

Results posted on

2015-02-09

Participant Flow

Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.

Participant milestones

Participant milestones
Measure	Cobas® 4800 HPV Test The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
Baseline, Cross-sectional Phase STARTED	47208
Baseline, Cross-sectional Phase COMPLETED	45758
Baseline, Cross-sectional Phase NOT COMPLETED	1450
Longitudinal Follow-up Phase STARTED	10002
Longitudinal Follow-up Phase COMPLETED	5020
Longitudinal Follow-up Phase NOT COMPLETED	4982

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cobas® 4800 HPV Test n=46887 Participants The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
Age, Continuous	39.8 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	46887 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

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

Population: Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).

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.

Outcome measures

Outcome measures
Measure	Cobas® 4800 HPV Test n=1578 Participants The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
Percentage of Participants With a Diagnosis of ≥ CIN2 Positive cobas 4800 HPV test result - n=514	14.0 Percentage of participants
Percentage of Participants With a Diagnosis of ≥ CIN2 Negative cobas 4800 HPV test result - n=1064	0.8 Percentage of participants

SECONDARY outcome

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

Population: Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).

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.

Outcome measures

Outcome measures
Measure	Cobas® 4800 HPV Test n=1578 Participants The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
Percentage of Participants With a Diagnosis of ≥ CIN3 Positive cobas 4800 HPV test result - n=514	8.4 Percentage of participants
Percentage of Participants With a Diagnosis of ≥ CIN3 Negative cobas 4800 HPV test result - n=1064	0.3 Percentage of participants

Adverse Events

Cobas® 4800 HPV Test

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cobas® 4800 HPV Test n=47208 participants at risk The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
Vascular disorders Urogenital haemorrhage	0.00% 1/47208 Safety population: All enrolled participants. Non-serious adverse events were not recorded in this study.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER