Clinical trial · Observational
Cervical Cancer Screening With Human Papillomavirus Testing
Multicentric Study of Cervical Cancer Screening and Triage With Human Papillomavirus (HPV) Testing
NCT01881659CI-TRIAL-00064668ESTAMPAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN2 | — | UNRESOLVED | — |
| CIN3 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women attending cervical screening
- description
- Women aged 30-64 years who signed informed consent and comply with inclusion and exclusion criteria.
- interventionNames
- Other: HPV screening
Primary outcomes (1)
- measure
- Number of participants with histologically confirmed cervical intraepithelial neoplasia grade 3 or cancer (CIN3+), including CIN2 positive for p16, on reviewed histology
- timeFrame
- Detected after initial HPV screening or at second screening round 18 months since entry
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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)
References
Publications (5)
- DERIVEDBaena 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
- DERIVEDKacperczyk-Bartnik J, El Hajj H, Toth I, Bizzarri N, Toth R, Razumova Z, Zwimpfer TA, Taumberger N, Bilir E, Strojna A, Angeles MA, Gasimli K, Nikolova T, Bartnik P, Cokan A, Sari SY, Kahramanoglu I, Caruso G, Joura EA, Kyrgiou M, Kesic V, Fagotti A, Arbyn M, Gultekin M. Declaration on cervical cancer elimination: literature review and perspectives from early-career clinicians. Int J Gynecol Cancer. 2025 Jul;35(7):101902. doi: 10.1016/j.ijgc.2025.101902. Epub 2025 Apr 26. PMID 40435891
- DERIVEDBaena 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
- DERIVEDAlmonte 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.