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HPV FOCAL Study: human papillomavirus testing for cervical cancer screening
ISRCTN ISRCTN79347302
DOI 10.1186/ISRCTN79347302
ClinicalTrials.gov identifier
EudraCT number
Public title HPV FOCAL Study: human papillomavirus testing for cervical cancer screening
Scientific title A multicentre randomised controlled parallel group evaluation of Human PapillomaVirus testing for cervical cancer screening
Acronym HPV FOCAL
Serial number at source MCT-82072
Study hypothesis 1. Establish efficacy of human papillomavirus (HPV) testing as stand alone screening test with cytology triage of HPV positive women
2. Establish an appropriate screening interval for HPV negative women
3. Determine cost-effectiveness of HPV testing as a primary screening test

As of 10/01/2011 this record was updated; all changes can be found in the relevant field under the above update date. At this time, the target number of participants was extended from 33,000 to ~28,000.
Lay summary
Ethics approval Received from the Research Ethics Board of the University of British Columbia-British Columbia Cancer Agency (Canada) on the 3rd April 2007 (ref: H06-04032).
Study design Multicentre, three arm, randomised parallel trial on diagnostic strategy with data analyst blinding
Countries of recruitment Canada
Disease/condition/study domain Human papillomavirus (HPV), cervical cancer
Participants - 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
Participants - 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
Anticipated start date 01/08/2007
Anticipated end date 31/12/2014
Status of trial Ongoing
Patient information material Can be found at http://www.bccancer.bc.ca/hpvfocal
Target number of participants ~28,000
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, only with cytology so the results correlate with women in the control arm. Those who are HPV positive on the initial screening test will be managed the same way as HPV positive women in the four-year intervention arm.

2. HPV testing four-year intervention arm - 24. a.2.d. experimental intervention dose, duration, etc - LBC sample will only be tested for HPV:
HPV negatives will have their exit screen at four years (or earlier if deemed by Data Safety and Monitoring Committee) when they will be screened with HPV and cytology testing and those positive on either test referred for Colposcopy. HPV positive on their initial screen will have the residual of that specimen analysed with cytology.
a. If cytology negative they will be recalled at six month intervals for HPV/cytology testing and referred for colposcopy if greater than or equal to abnormal squamous cells of undertermined significance (ASCUS-US) at any recall or persistently HPV positive after three recalls
b. If cytology is greater than or equal to ASCUS-US they will be immediately referred for colposcopy and managed according to those results.

Amended as of 19/03/2009:
3. Control Arm - Conventional cytology with liquid based cytology -
On the basis of this result women will be managed as follows:
Within normal limits (negative results): Recalled for their next routine screen at 2 years, where the sample will undergo cytology testing. If negative again at the 2 year screen, recalled, for the exit screen at 4 years. At the 4 year exit screen, the sample obtained will undergo both HPV and cytology testing with those positive on either test being referred for colposcopy and then treated based on the colposcopy results.
ASC-H or greater than LSIL: (at recruitment visit or at the 2 year screen) will receive immediate colposcopy and treated based on the colposcopy results.
ASC-US: (at recruitment visit or at the 2 year screen) the residual of the specimen collected will undergo HPV testing. Follow-up based on the result of the HPV test:
a. HPV-positive: referred for immediate colposcopy and treated based on the colposcopy results
b. HPV-negative: recalled for repeat cytology testing in 12 months. If greater than or equal to ASC-US, referred for colposcopy and treated based on the colposcopy results. If cytology negative they will be returned to the routine screening pool for this arm.

Initial information at time of registration:
3. Control Arm - Conventional cytology with liquid based cytology - 24. b.1.cd. control intervention dose, duration, etc:
Liquid based cytology sample processed for cytology and followed according to existing provincial guidelines. Recalled again at two years for their second routine screen and at four years for their exit screen where they will be screened with cytology and HPV testing.

Added 10/01/2011:
Recruitment to the safety arm will terminate December 31, 2010 and from that point forward, women will be randomized 1:1 into the cytology or intervention arms only. A total of ~28,000 women (11,000 each in the Control and Intervention arms respectively, and ~6,000 in the Safety arm) will be enrolled in the FOCAL trial.

Contact for public queries:
Laurie Smith BN RN CCRP
Manager, HPV FOCAL Study
BC Cancer Agency
711-750 West Broadway
Vancouver BC, V5Z 1H6
Canada
Tel: +1 604 877 6098 ext. 4829
Fax: +1 604 877 6115
Email: lsmith3@bccancer.bc.ca
Primary outcome measure(s) 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 outcome measure(s) Clearance of HPV infection in women who are HPV positive at recruitment, measured at two and four years.
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-82072)
Trial website http://www.bccancer.bc.ca/hpvfocal/
Publications 2010 preliminary results in http://www.ncbi.nlm.nih.gov/pubmed/20334685
Contact name Dr  Andrew J  Coldman
  Address BC Cancer Agency
8th floor, 686 W Broadway
Vancouver
  City/town British Columbia
  Zip/Postcode V5Z 1G1
  Country Canada
  Tel +1 604 877 6143
  Fax +1 604 660 3645
  Email acoldman@bccancer.bc.ca
Sponsor Provincial Health Services Authority (Canada)
  Address Finance Department
Suite 260, 1770 West 7th Avenue
Vancouver
  City/town British Columbia
  Zip/Postcode V6J 4Y6
  Country Canada
  Sponsor website: http://www.phsa.ca/default.htm
Date applied 20/04/2007
Last edited 10/01/2011
Date ISRCTN assigned 20/04/2007
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