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Cervical Cancer Screening With Human Papillomavirus Testing
Conditions
CIN3 - CIN2 - Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical cancer, cancer prevention, cervical screening, HPV testing, triage techniques
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: HPV screening
Type: Other
Overall Status
Recruiting
Summary
HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.
Detailed Description
The study will be conducted in several Latin American countries. Currently, the study has started in one site in Colombia and soon another site in Mexico will start. In each participating center, women aged 30-64 years who are attending clinics for cervical screening will be invited to participate in the study. Women who agree to participate and sign the corresponding Institutional Review Board (IRB) approved consent forms will undergo a pelvic examination, and cervical cells for primary screening and triage will be collected. Recruitment specimens will be used for primary screening with an established HPV DNA test (Food and Drug Administration FDA approved). All women who are HPV-positive by the recruitment test will be referred for a standardized colposcopy examination for diagnosis. At the colposcopy visit, but before colposcopy is performed, a risk factor interview will be administered and participants will undergo visual inspection of the cervix with acetic acid (VIA) and collection of additional cervical cells and a blood specimen. The results of VIA will not be disclosed to the colposcopist. During colposcopy, the colposcopists will obtain (2-4) biopsies from any abnormally-appearing areas to ascertain neoplastic outcomes (CIN3+) and to direct treatment as required. All women who attend colposcopy will have a second round of HPV testing approximately 18 months after recruitment and those who are HPV-positive will be referred to colposcopy for final diagnosis. Data management and study supervision will be the responsibility of the International Agency for Research on Cancer (IARC) and the local Principal Investigators, most of whom are experienced HPV researchers.
The combined number of histologically-confirmed diagnoses of CIN3+, including CIN2 lesions positive for p16, (estimated n=500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. Our initial analyses will focus on comparisons of triage strategies that employ a single method: VIA, conventional/liquid-based cytology, HPV DNA genotyping, HPV RNA detection, detection of E6 proteins of high risk HPV types, or markers of HPV-induced cell-cycle alterations (e.g., p16, ki67, etc). To the extent possible, molecular testing for HPV triage will be carried out on the recruitment specimens to simulate a 'reflex testing' approach wherein screening and triage are done on the same specimen without additional visits. Subsequent analyses will consider various alternative strategies that employ more than one triage methodology; e.g., HPV DNA genotyping followed by cytology. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost, and effectiveness.
The combined number of histologically-confirmed diagnoses of CIN3+, including CIN2 lesions positive for p16, (estimated n=500) will be the outcome of primary interest for evaluation of the performance of the various triage modalities. Our initial analyses will focus on comparisons of triage strategies that employ a single method: VIA, conventional/liquid-based cytology, HPV DNA genotyping, HPV RNA detection, detection of E6 proteins of high risk HPV types, or markers of HPV-induced cell-cycle alterations (e.g., p16, ki67, etc). To the extent possible, molecular testing for HPV triage will be carried out on the recruitment specimens to simulate a 'reflex testing' approach wherein screening and triage are done on the same specimen without additional visits. Subsequent analyses will consider various alternative strategies that employ more than one triage methodology; e.g., HPV DNA genotyping followed by cytology. The effectiveness and costs of each alternative strategy will be assessed under various scenarios of feasibility, cost, and effectiveness.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 64 Years
Minimum Age: 30 Years
Gender: Female
Criteria: Inclusion Criteria:
- Aged 30-64 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff
- Physically able to have a pelvic exam
Exclusion Criteria:
- Reporting no previous sexual activity
- History of cervical cancer
- Previous treatment for cervical pre-cancer in the last six months
- Hysterectomy
- Plans to move out of the study area in the next 12 months
- Screened for cervical cancer in the last 12 months (depending on local regulations)
- Aged 30-64 years
- Mentally competent to be able to understand the consent form
- Able to communicate with study staff
- Physically able to have a pelvic exam
Exclusion Criteria:
- Reporting no previous sexual activity
- History of cervical cancer
- Previous treatment for cervical pre-cancer in the last six months
- Hysterectomy
- Plans to move out of the study area in the next 12 months
- Screened for cervical cancer in the last 12 months (depending on local regulations)
Locations
National Cancer Institute of Colombia
Bogota, Colombia
Universidad de Antioquia
Status: Recruiting
Contact: Carolina Wiesner, MD - +5713341111 - cwiesner@cancer.gov.co
Medellin, Colombia
Social Security Institute of Costa Rica
Status: Recruiting
Contact: Gloria I Sanchez, PhD - +5742196062 - sanchezg@une.net.co
San Jose, Costa Rica
Universidad Nacional Autonoma de Honduras
Status: Not yet recruiting
Contact: Luis B Saenz, MD - +50622223353 - lbsaenz@ccss.sa.cr
Tegucigalpa, Honduras
Instituto Nacional de Salud Publica de Mexico
Status: Recruiting
Contact: Annabelle Ferrera, PhD - +50499902713 - bozaferrera@gmail.com
Cuernavaca, Morelos, Mexico
Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asuncion
Status: Not yet recruiting
Contact: Aurelio Cruz, MD, PhD - +527773293020 - acruz@insp.mx
Asuncion, Paraguay
Comision Honoraria de Lucha contra el Cancer
Status: Recruiting
Contact: Elena Kasamatsu, MD - +59521446459 - ekasabalbo@gmail.com
Montevideo, Uruguay
Status: Recruiting
Contact: Guillermo Rodriguez, MD - +59824020807 - rodriguezg@urucan.org.uy
Start Date
June 2013
Completion Date
September 2018
Sponsors
International Agency for Research on Cancer
Source
International Agency for Research on Cancer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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