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Human Papilloma Virus (HPV)NCT00709891

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

A study testing cobas® 4800 HPV Test in people with Human Papilloma Virus (HPV), run by Hoffmann-La Roche at 61 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Human Papilloma Virus (HPV)
What is being tested?
cobas® 4800 HPV Test
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47,208 participants
Where
61 sitesUnited States
Study dates
May 2008to Jun 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United States61 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boynton Beach, Florida, 8188

  • Study site

    Carmichael, California, 95608

  • Study site

    Champaign, Illinois, 61820

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Colorado Springs, Colorado, 80910

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Costa Mesa, California, 92617

  • Study site

    Covington, Louisiana, 70433

  • Study site

    Dallas, Texas, 75230

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Englewood, Ohio, 45342

  • Study site

    Enterprise, Alabama, 36331

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fountain Valley, California, 92708-5153

  • Study site

    Hilton Head, South Carolina, 29926

  • Study site

    Hoover, Alabama, 35216

  • Study site

    Houston, Texas, 77054

  • Study site

    Indianapolis, Indiana, 46268

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jacksonville, Florida, 32259

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Louisville, Kentucky, 40291

  • Study site

    McAllen, Texas, 78503

  • Study site

    Miami, Florida, 33143

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Moorestown, New Jersey, 08057

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    Newburgh, Indiana, 47360

  • Study site

    North Charleston, South Carolina, 29406

  • Study site

    North Miami, Florida, 33161

  • Study site

    Paducah, Kentucky, 42003

  • Study site

    Phoenix, Arizona, 85015

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Roswell, Georgia, 30075

  • Study site

    Ruston, Louisiana, 71270

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Diego, California, 92123

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33613

  • Study site

    Temple, Texas, 76508

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tucson, Arizona, 85755

  • Study site

    Virginia Beach, Virginia, 23456

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    West Reading, Pennsylvania, 19611

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Being tested
cobas® 4800 HPV Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cobas® 4800 HPV TestDevice

Study groups in NCT00709891
Study groupRoleWhat they receive
cobas® 4800 HPV TestExperimentalThe 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.
Receives: Device: cobas® 4800 HPV Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
47,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00709891
Sponsor's protocol ID
RD000649
Other IDs
MWP-HPV-159
Status last verified
Feb 2015
First submitted
30 Jun 2008
Last updated
9 Feb 2015

Publications

  • 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.

    PubMed 25667973

  • 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.

    PubMed 24122508

  • 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.

    PubMed 21865084

Questions about this trial

What is this clinical trial studying?

A study testing cobas® 4800 HPV Test in people with Human Papilloma Virus (HPV), run by Hoffmann-La Roche at 61 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Diagnosis of ≥ CIN2 (time frame: Baseline to the end of the Baseline period (up to 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00709891, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.

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