Trial Title:
Cervical Cancer Screening With Human Papillomavirus Testing
NCT ID:
NCT01881659
Condition:
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
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
HPV screening
Description:
Women who signed informed consent will be screened with HPV testing.
Arm group label:
Women attending cervical screening
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.
Criteria for eligibility:
Study pop:
This is a multicentric study to be carried out in countries across the Latin American
region. At each site, a census of all women 28-64 years of age residents of the selected
area will be done previously to the start of the study. All women will then be invited
using different approaches to the local health centers where screening is to happen.
Sampling method:
Non-Probability Sample
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)
Gender:
Female
Minimum age:
30 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hopsital de Clinicas
Address:
City:
Buenos Aires
Country:
Argentina
Facility:
Name:
Insituto Malbran - Hospital Posadas
Address:
City:
Buenos Aires
Country:
Argentina
Facility:
Name:
Universidad San Francisco Xavier de Chuquisaca
Address:
City:
Sucre
Country:
Bolivia
Facility:
Name:
National Cancer Institute of Colombia
Address:
City:
Bogota
Country:
Colombia
Facility:
Name:
Universidad de Antioquia
Address:
City:
Medellin
Country:
Colombia
Facility:
Name:
Social Security Institute of Costa Rica
Address:
City:
San Jose
Country:
Costa Rica
Facility:
Name:
Universidad Nacional Autonoma de Honduras
Address:
City:
Tegucigalpa
Country:
Honduras
Facility:
Name:
Instituto Nacional de Salud Publica de Mexico
Address:
City:
Cuernavaca
Country:
Mexico
Facility:
Name:
Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asuncion
Address:
City:
Asuncion
Country:
Paraguay
Facility:
Name:
Laboratorio Central de Salud Publica
Address:
City:
Asuncion
Country:
Paraguay
Facility:
Name:
Hospital Santa Rosa
Address:
City:
Lima
Country:
Peru
Facility:
Name:
Comision Honoraria de Lucha contra el Cancer
Address:
City:
Montevideo
Zip:
11200
Country:
Uruguay
Start date:
May 2013
Completion date:
December 31, 2023
Lead sponsor:
Agency:
International Agency for Research on Cancer
Agency class:
Other
Source:
International Agency for Research on Cancer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01881659
