Human Papilloma Virus (HPV)
Conditions
Brief 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.
Interventions
DEVICEcobas® 4800 HPV Test
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Diagnosis of ≥ CIN2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Diagnosis of ≥ CIN3 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46,887 |
| Total | 46,887 |
Baseline characteristics
| Characteristic | Cobas® 4800 HPV Test |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 46887 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 1 / 47,208 |
Outcome results
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cobas® 4800 HPV Test | Percentage of Participants With a Diagnosis of ≥ CIN2 | Positive cobas 4800 HPV test result - n=514 | 14.0 Percentage of participants |
| Cobas® 4800 HPV Test | Percentage of Participants With a Diagnosis of ≥ CIN2 | Negative cobas 4800 HPV test result - n=1064 | 0.8 Percentage of participants |
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cobas® 4800 HPV Test | Percentage of Participants With a Diagnosis of ≥ CIN3 | Positive cobas 4800 HPV test result - n=514 | 8.4 Percentage of participants |
| Cobas® 4800 HPV Test | Percentage of Participants With a Diagnosis of ≥ CIN3 | Negative cobas 4800 HPV test result - n=1064 | 0.3 Percentage of participants |