Cervical Cancer Screening With Human Papillomavirus Testing

NCT01881659 | Unknown DMC

• 1 other identifier: IEC 12-27
• Study Type: observational
• Target: 50,000
• Locations: 8 countries
• Sites: 11

Brief 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.

Conditions

CIN3; CIN2; Cervical Cancer

Keywords

cervical cancer; cancer prevention; cervical screening; HPV testing; triage techniques

Outcome Measures

Primary Outcomes (1)

• Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology

  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 Outcomes (1)

• Number of participants with histologically confirmed CIN2, CIN3 or cancer (CIN2+) on reviewed histology

  Detected after initial HPV screening or at second screening round 18 months since entry

Study Arms (1)

Women attending cervical screening

Women aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria.

Other: HPV screening

Interventions

HPV screening OTHER

Women who signed informed consent will be screened with HPV testing.

Women attending cervical screening

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• International Agency for Research on Cancer: lead

Study Sites (12)

Hopsital de Clinicas

Buenos Aires, Argentina

Location

Insituto Malbran - Hospital Posadas

Buenos Aires, Argentina

Location

Universidad San Francisco Xavier de Chuquisaca

Sucre, Bolivia

Location

National Cancer Institute of Colombia

Bogotá, Colombia

Location

Universidad de Antioquia

Medellín, Colombia

Location

Social Security Institute of Costa Rica

San José, Costa Rica

Location

Universidad Nacional Autonoma de Honduras

Tegucigalpa, Honduras

Location

Instituto Nacional de Salud Publica de Mexico

Cuernavaca, Morelos, Mexico

Location

Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asuncion

Asunción, Paraguay

Location

Laboratorio Central de Salud Publica

Asunción, Paraguay

Location

Hospital Santa Rosa

Lima, Peru

Location

Comision Honoraria de Lucha contra el Cancer

Montevideo, 11200, Uruguay

Location

Related Publications (4)

• Baena A, Picconi MA, Mendoza L, Ferrera A, Mesher D, Lineros J, Brizuela M, Mongelos P, Cabrera Y, Fellner MD, Zambrana O, Garcia L, Hernandez P, Bobadilla ML, Ramon M, Venegas G, Villagra V, Cruz A, Rodriguez G, Teran C, Calderon A, Wiesner C, Herrero R, Almonte M; ESTAMPA study group. Short-term repeat HPV testing for triaging HPV-positive women in cervical cancer screening. Br J Cancer. 2025 Dec;133(12):1844-1853. doi: 10.1038/s41416-025-03193-0. Epub 2025 Oct 3.

  PMID: 41044173 DERIVED

• Baena A, Mesher D, Salgado Y, Martinez S, Villalba GR, Amarilla ML, Salgado B, Flores B, Bellido-Fuentes Y, Alvarez-Larraondo M, Valls J, Lora O, Virreira-Prout G, Figueroa J, Turcios E, Soilan AM, Ortega M, Celis M, Gonzalez M, Venegas G, Teran C, Ferrera A, Mendoza L, Kasamatsu E, Murillo R, Wiesner C, Broutet N, Luciani S, Herrero R, Almonte M; ESTAMPA study group. Performance of visual inspection of the cervix with acetic acid (VIA) for triage of HPV screen-positive women: results from the ESTAMPA study. Int J Cancer. 2023 Apr 15;152(8):1581-1592. doi: 10.1002/ijc.34384. Epub 2022 Dec 7.

  PMID: 36451311 DERIVED

• Almonte M, Murillo R, Sanchez GI, Gonzalez P, Ferrera A, Picconi MA, Wiesner C, Cruz-Valdez A, Lazcano-Ponce E, Jeronimo J, Ferreccio C, Kasamatsu E, Mendoza L, Rodriguez G, Calderon A, Venegas G, Villagra V, Tatti S, Fleider L, Teran C, Baena A, Hernandez ML, Rol ML, Lucas E, Barbier S, Ramirez AT, Arrossi S, Rodriguez MI, Gonzalez E, Celis M, Martinez S, Salgado Y, Ortega M, Beracochea AV, Perez N, Rodriguez de la Pena M, Ramon M, Hernandez-Nevarez P, Arboleda-Naranjo M, Cabrera Y, Salgado B, Garcia L, Retana MA, Colucci MC, Arias-Stella J, Bellido-Fuentes Y, Bobadilla ML, Olmedo G, Brito-Garcia I, Mendez-Herrera A, Cardinal L, Flores B, Penaranda J, Martinez-Better J, Soilan A, Figueroa J, Caserta B, Sosa C, Moreno A, Mural J, Doimi F, Gimenez D, Rodriguez H, Lora O, Luciani S, Broutet N, Darragh T, Herrero R. Multicentric study of cervical cancer screening with human papillomavirus testing and assessment of triage methods in Latin America: the ESTAMPA screening study protocol. BMJ Open. 2020 May 24;10(5):e035796. doi: 10.1136/bmjopen-2019-035796.

  PMID: 32448795 DERIVED

• Robles C, Wiesner C, Martinez S, Salgado Y, Hernandez M, Lucas E, Lineros J, Romero P, Herrero R, Almonte M, Murillo R. Impact of operational factors on HPV positivity rates in an HPV-based screening study in Colombia. Int J Gynaecol Obstet. 2018 Oct;143(1):44-51. doi: 10.1002/ijgo.12574. Epub 2018 Jul 16.

  PMID: 29944728 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

One dry and two liquid cervical samples will be collected at entry. Sample fate will depend on a liquid HPV test. If positive: the dry sample will be used for the E6 protein strip test, the liquid sample for liquid-based cytology and the p16/ki67 test, and 10 aliquots from the second liquid sample will be stored. If negative: the dry sample will be stored for the E6 strip test until the end of the study. Testing will be done based on evidence towards usefulness in primary screening, two aliquots from the first liquid sample will be stored and, the second liquid sample will be discharged. At initial colposcopy, a cervical sample (6 aliquots) and a 10mL blood sample (serum, plasma and buffy-coat) will be collected and stored. All samples will be used for testing of triage techniques.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Rolando Herrero, MD, PhD

  International Agency for Research on Cancer (IARC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: May 1, 2013
• Primary Completion: August 30, 2022
• Study Completion: December 31, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

AR (2); CO (2); UR (1); BO (1); PE (1); HO (1); ME (1); PA (2)