Cervical Cancer Screening With Human Papillomavirus Testing (ESTAMPA)

March 13, 2023 updated by: International Agency for Research on Cancer

Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hopsital de Clinicas
      • Buenos Aires, Argentina
        • Insituto Malbran - Hospital Posadas
  • Bolivia
      • Sucre, Bolivia
        • Universidad San Francisco Xavier de Chuquisaca
  • Colombia
      • Bogota, Colombia
        • National Cancer Institute of Colombia
      • Medellin, Colombia
        • Universidad de Antioquia
  • Costa Rica
      • San Jose, Costa Rica
        • Social Security Institute of Costa Rica
  • Honduras
      • Tegucigalpa, Honduras
        • Universidad Nacional Autonoma de Honduras
  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Instituto Nacional de Salud Publica de Mexico
  • Paraguay
      • Asuncion, Paraguay
        • Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asuncion
      • Asuncion, Paraguay
        • Laboratorio Central de Salud Publica
  • Peru
      • Lima, Peru
        • Hospital Santa Rosa
  • Uruguay
      • Montevideo, Uruguay, 11200
        • Comision Honoraria de Lucha contra el Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women attending cervical screening
Women aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria.
Other: HPV screening
Women who signed informed consent will be screened with HPV testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology
Time Frame: Detected after initial HPV screening or at second screening round 18 months since entry

There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.

Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Detected after initial HPV screening or at second screening round 18 months since entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology
Time Frame: Detected after initial HPV screening or at second screening round 18 months since entry

There will be two HPV screening rounds. Women who test negative for HPV at initial screening will finish their participation. HPV positive women will be: 1) referred to colposcopy, 2) invited for a second HPV screening round if not yet treated, and 3) referred to final colposcopy if HPV positive at second screening. Clinical management will be based on local histology.

Histology specimens will be externally reviewed by one highly experience international pathologist. If the local and external results are the same, this will become the final histology. If there is disagreement, the specimen will be sent to a third pathologist (be blinded to previous readings). The final diagnosis will then be that agreed by two pathologists (local and either external or both external). Remaining discrepancies will be solved by adjudication at a multi-headed microscope. Worst histology on review will be used to define outcome measures.
Detected after initial HPV screening or at second screening round 18 months since entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Investigators

  • Principal Investigator: Rolando Herrero, MD, PhD, International Agency For Research On Cancer (IARC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC 12-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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