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| ID | Type | Description | Link |
|---|---|---|---|
| MWP-HPV-159 | Other Identifier | Roche Molecular Systems, Inc. |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cobas® 4800 HPV Test | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cobas® 4800 HPV Test | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Behrens | Roche Molecular Systems, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enterprise | Alabama | 36331 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25667973 | Derived | Monsonego J, Cox JT, Behrens C, Sandri M, Franco EL, Yap PS, Huh W. Prevalence of high-risk human papilloma virus genotypes and associated risk of cervical precancerous lesions in a large U.S. screening population: data from the ATHENA trial. Gynecol Oncol. 2015 Apr;137(1):47-54. doi: 10.1016/j.ygyno.2015.01.551. Epub 2015 Feb 8. | |
| 24122508 |
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Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline, Cross-sectional Phase |
|
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| Hoover |
| Alabama |
| 35216 |
| United States |
| Mobile | Alabama | 36608 | United States |
| Phoenix | Arizona | 85015 | United States |
| Phoenix | Arizona | 85032 | United States |
| Tucson | Arizona | 85712 | United States |
| Tucson | Arizona | 85755 | United States |
| Beverly Hills | California | 90211 | United States |
| Carmichael | California | 95608 | United States |
| Costa Mesa | California | 92617 | United States |
| Fountain Valley | California | 92708-5153 | United States |
| San Diego | California | 92123 | United States |
| Colorado Springs | Colorado | 80910 | United States |
| Lakewood | Colorado | 80228 | United States |
| Boynton Beach | Florida | 8188 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Jacksonville | Florida | 32216 | United States |
| Jacksonville | Florida | 32259 | United States |
| Jupiter | Florida | 33458 | United States |
| Lake Worth | Florida | 33461 | United States |
| Miami | Florida | 33143 | United States |
| North Miami | Florida | 33161 | United States |
| Sarasota | Florida | 34239 | United States |
| Tampa | Florida | 33613 | United States |
| West Palm Beach | Florida | 33401 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Atlanta | Georgia | 30328 | United States |
| Decatur | Georgia | 30033 | United States |
| Roswell | Georgia | 30075 | United States |
| Boise | Idaho | 83712 | United States |
| Champaign | Illinois | 61820 | United States |
| Indianapolis | Indiana | 46268 | United States |
| Newburgh | Indiana | 47360 | United States |
| Louisville | Kentucky | 40291 | United States |
| Paducah | Kentucky | 42003 | United States |
| Covington | Louisiana | 70433 | United States |
| Ruston | Louisiana | 71270 | United States |
| Saginaw | Michigan | 48604 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Moorestown | New Jersey | 08057 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Englewood | Ohio | 45342 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Columbia | South Carolina | 29201 | United States |
| Hilton Head | South Carolina | 29926 | United States |
| North Charleston | South Carolina | 29406 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Johnson City | Tennessee | 37604 | United States |
| Nashville | Tennessee | 37203 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77054 | United States |
| McAllen | Texas | 78503 | United States |
| Temple | Texas | 76508 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Virginia Beach | Virginia | 23456 | United States |
| Tacoma | Washington | 98405 | United States |
| Wright TC Jr, Stoler MH, Behrens CM, Sharma A, Sharma K, Apple R. Interlaboratory variation in the performance of liquid-based cytology: insights from the ATHENA trial. Int J Cancer. 2014 Apr 15;134(8):1835-43. doi: 10.1002/ijc.28514. Epub 2013 Oct 29. |
| 21865084 | Derived | Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 2011 Sep;12(9):880-90. doi: 10.1016/S1470-2045(11)70188-7. Epub 2011 Aug 22. |
| COMPLETED |
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| NOT COMPLETED |
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| Longitudinal Follow-up Phase |
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Eligible population: All participants who met the study inclusion/exclusion criteria, had not been enrolled in the study previously, and had not withdrawn consent before undergoing any study procedures. Of the enrolled population, 321 participants did not meet these criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US). | Posted | Number | Percentage of participants | Baseline to the end of the Baseline period (up to 12 weeks) |
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|
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| 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. | Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US). | Posted | Number | Percentage of participants | Baseline to the end of the study (up to 5 years, 1 month) |
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Safety population: All enrolled participants. Non-serious adverse events were not recorded in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 47,208 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urogenital haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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