HPV FOCAL study: human papillomavirus testing for cervical cancer screening

Conditions

Human papillomavirus (HPV), cervical cancer Cancer Cervical cancer

Laurie Smith, C. Sarai Racey, Lovedeep Gondara, Mel Krajden, Marette Lee et al. (12 authors)

BMJ Open2021-10-0116 citations

10.1136/bmjopen-2021-052084

Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months

Gina Ogilvie, Dirk van Niekerk, Mel Krajden, Laurie Smith, Darrel Cook et al. (15 authors)

JAMA2018-07-03268 citations

10.1001/jama.2018.7464

Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial.

Cook DA, Mei W, Smith LW, van Niekerk DJ, Ceballos K, Franco EL, Coldman AJ, Ogilvie GS, Krajden M.

2015-12-1631 citations

10.1186/s12885-015-1959-5

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial).

Ogilvie GS, van Niekerk DJ, Krajden M, Martin RE, Ehlen TG, Ceballos K, Peacock SJ, Smith LW, Kan L, Cook DA, Mei W, Stuart GC, Franco EL, Coldman AJ.

2010-03-2451 citations

10.1186/1471-2407-10-111

Interventions

1. HPV testing two-year safety check arm - liquid based cytology (LBC) sample tested only for HPV: Those who are HPV negative will be screened again in two years for their exit screen,

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Current information as of 04/11/2008: 1. Women aged 25 to 65 years 2. Registered with MSP 3. Attending a collaborating BC healthcare provider for regular cervical cancer screening (pap tests) Initial information at time of registration: 1. Women aged 25 to 65 years 2. British Columbia residents 3. Eligible for routine cervical screening

Exclusion criteria

Exclusion criteria: Current information as of 01/12/2009 (effective 25/11/2009): 1. Pap smear less than one year ago 2. Pregnant (at time of initial sample) 3. History of moderate to severe cervical intraepithelial neoplasia (greater than CIN2) requiring treatment less than 5 years ago 4. History of invasive cervical cancer at any time 5. Complete hysterectomy with cervix removal 6. Human immunodeficiency virus (HIV) positive or receiving immunosuppressive treatments 7. Unable or unwilling to sign the Information and Consent form Information as of 04/11/2008: 1. Pap smear less than one year ago 2. Pregnant 3. History of moderate to severe cervical intraepithelial neoplasia (greater than CIN2) requiring treatment less than 5 years ago 4. History of cervical cancer at any time 5. Complete hysterectomy with cervix removal 6. Human immunodeficiency virus (HIV) positive or receiving immunosuppressive treatments 7. Received HPV vaccination 8. Unable or unwilling to sign the Information and Consent form Initial information at time of registration: 1. Pregnant 2. History of cervical cancer 3. Hysterectomy 4. Human immunodeficiency virus (HIV) positive 5. Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 12/03/2018: 1. CIN grade 3 or greater (CIN3+) detected over the four years post recruitment in the control and intervention arms evaluated and compared as a surrogate marker for estimating reductions in incidence of cervical cancer, measured at four years Previous primary outcome measures: 1. Histologically confirmed cervical intraepithelial neoplasia (CIN) greater than or equal to grade two detected at two years in both the control and safety-check arms 2. CIN grade three (CIN3) or greater detected over the four years post recruitment in the control and intervention arms evaluated and compared as a surrogate marker for estimating reductions in incidence of cervical cancer, measured at four years 3. Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to six month re-testing, measured at two years 4. Total estimated cost per woman screened and total estimated cost per quality-adjusted life-year gained for each technology, measured at four years	—

Measure

Time frame

Current primary outcome measures as of 12/03/2018: 1. CIN grade 3 or greater (CIN3+) detected over the four years post recruitment in the control and intervention arms evaluated and compared as a surrogate marker for estimating reductions in incidence of cervical cancer, measured at four years Previous primary outcome measures: 1. Histologically confirmed cervical intraepithelial neoplasia (CIN) greater than or equal to grade two detected at two years in both the control and safety-check arms 2. CIN grade three (CIN3) or greater detected over the four years post recruitment in the control and intervention arms evaluated and compared as a surrogate marker for estimating reductions in incidence of cervical cancer, measured at four years 3. Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to six month re-testing, measured at two years 4. Total estimated cost per woman screened and total estimated cost per quality-adjusted life-year gained for each technology, measured at four years

—

Secondary

Measure	Time frame
Current secondary outcome measures: 1. Histologically confirmed cervical intraepithelial neoplasia grade 2 or greater (CIN2+) two detected at two years in both the control and safety-check arms 2. CIN2+ detected in the control and intervention arms over the four years post recruitment 3. Clearance of HPV infection in women who are HPV positive at recruitment, measured at two and four years 4. Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 12 month re-testing, measured at two years 5. Evaluation of the impact of primary HPV testing on colposcopy services through evaluation of colposcopy referral rates in each arm through the trial follow-up period 6. Total estimated cost per woman screened and total estimated cost per quality-adjusted life-year gained for each technology, measured at four years Previous secondary outcome measures: Clearance of HPV infection in women who are HPV positive at recruitment, measured at two and four years	—

Measure

Time frame

Current secondary outcome measures: 1. Histologically confirmed cervical intraepithelial neoplasia grade 2 or greater (CIN2+) two detected at two years in both the control and safety-check arms 2. CIN2+ detected in the control and intervention arms over the four years post recruitment 3. Clearance of HPV infection in women who are HPV positive at recruitment, measured at two and four years 4. Detection of histologically confirmed greater than or equal to CIN3 in the participants allocated to 12 month re-testing, measured at two years 5. Evaluation of the impact of primary HPV testing on colposcopy services through evaluation of colposcopy referral rates in each arm through the trial follow-up period 6. Total estimated cost per woman screened and total estimated cost per quality-adjusted life-year gained for each technology, measured at four years Previous secondary outcome measures: Clearance of HPV infection in women who are HPV positive at recruitment, measured at two and four years

—

Countries

Canada

Contacts

Public ContactLaurie Smith

lsmith3@bccancer.bc.ca+1 (0)604 877 6098 ext. 4829

Outcome results

None listed