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Molecular Diagnostics

Italian guidelines for cervical cancer screening. Multisocietal recommendations on the use of biomarkers in HPV screening with risk-based approach and GRADE methodology

British Journal of Cancer (2025)Cite this article

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Abstract

The European Council recommends adopting risk-based screening when relevant. In triaging HPV-positive women, it can be an effective strategy to reduce overtreatment and referral to colposcopy. HPV genotyping and p16/ki67 expression may allow a better risk stratification than cytology. In Italy, recommendations on their use (alone or combined) in screening were developed by a multi-professional (nine scientific societies) and multidisciplinary working group (including patients and decision makers). Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision frameworks were used. Data from large clinical trials on screening populations with long follow-up instructed the biomarkers’ evaluation. The working group defined the CIN3+ risk thresholds (a surrogate marker of cancer risk) to guide decisions on management: immediate colposcopy, referral to 1-year and 3-year retesting. The risk-based approach allowed to reduce the number of possible strategies to be compared to five specific healthcare questions framed as PICOs. The prioritised outcomes were risk of cancer and of CIN3+ in HPV+/triage-negative women, number of colposcopies, number of samples to be taken, and number of unneeded treatments. The combination of morphological markers (cytology or p16/ki67) and extended HPV genotyping was the only strategy with a conditional recommendation in favour when compared with cytology.

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Fig. 1: CIN3+ risk groups and linked management adopted by the Italian Multisocietal Guidelines for Cervical Cancer Prevention.
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Data availability

The guideline development project and final recommendations were published on the database of the Italian National System of Guidelines (SNLG) of the National Institute of Health (ISS) (Sistema Nazionale Linee Guida, Istituto Superiore di Sanità). https://www.iss.it/-/snlg-prevenzione-carcinoma-cervice-uterina. It includes the complete Evidence-to-Decision and Summary of Findings tables (and relative references), and is available upon request to the corresponding author; simplified copies are included in the Supplementary material.

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Acknowledgements

We thank Paola Lippi for her valuable support.

Author information

Author notes

  1. These authors contributed equally: Silvia Gori, Francesco Venturelli.

  2. These authors jointly supervised this work: Paolo Giorgi Rossi, Annarosa Del Mistro.

Authors and Affiliations

  1. Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy

    Silvia Gori, Annarosa Del Mistro & Helena Frayle

  2. Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy

    Francesco Venturelli & Paolo Giorgi Rossi

  3. Università di Firenze, Firenze, Italy

    Francesca Carozzi

  4. GISCi, proposing society, Padova, Italy

    Tiziano Maggino & Basilio Passamonti

  5. AIO; Azienda Sanitaria Universitaria Giuliano-Isontina, Trieste, Italy

    Roberta Giornelli

  6. AOGOI; Freelance, Genova, Italy

    Paolo Cristoforoni

  7. SIAPEC-IAP; Ospedale Centrale, Bolzano, Italy

    Giovanni Negri

  8. SICi, Roma, Italy

    Antonella Pellegrini

  9. SICPCV; Ospedale Cardinal Massaia, Asti, Italy

    Maggiorino Barbero

  10. SIGO; Università degli studi, Milano, Italy

    Filippo Murina

  11. SItI; Assessorato alla Salute e Politiche Sociali, Provincia Autonoma di Trento, Trento, Italy

    Emanuele Torri

  12. SIV-ISV; Istituto Nazionale Tumori - IRCCS “Fondazione G. Pascale”, Napoli, Italy

    Franco Maria Buonaguro & Maria Lina Tornesello

  13. Istituto per lo Studio la Prevenzione e la Rete Oncologica, ISPRO, Firenze, Italy

    Paola Mantellini, Anna Iossa, Simonetta Bisanzi, Filippo Cellai, Cristina Sani, Carmen Beatriz Visioli & Marco Zappa

  14. Università di Ferrara, Ferrara, Italy

    Paola Garutti

  15. Città della Salute, Torino, Italy

    Anna Gillio Tos, Elena Allia, Paola Armaroli, Laura De Marco & Luigia Macrì

  16. Patient representative, Padova, Italy

    Barbara Aguiari

  17. USL Toscana Centro, Firenze, Italy

    Karin Louise Andersson & Prassede Foxi

  18. IRCCS Istituto Nazionale Tumori Regina Elena, Roma, Italy

    Maria Benevolo

  19. USL Umbria 1, Perugia, Italy

    Annalisa Brozzetti, Simonetta Bulletti, Elena Cesarini, Daniela Gustinucci, Valeria Nofrini & Basilio Passamonti

  20. USL Toscana Sud Est, Arezzo, Italy

    Elena Burroni

  21. ASL02 Lanciano Vasto Chieti, Chieti, Italy

    Lucia Ciccocioppo

  22. Università di Milano Bicocca, Milano, Italy

    Clementina Cocuzza & Marianna Martinelli

  23. Ospedale Giovanni Paolo II, Lamezia Terme, Italy

    Concetta Fumia

  24. Abruzzo, Italy

    Vincenzo Maccallini

  25. Patient representative, Ferrara, Italy

    Serena Matarese

  26. Lanciano, Italy

    Tiziana Rotondo

  27. Regione Emilia-Romagna, Bologna, Italy

    Priscilla Sassoli de Bianchi

  28. ASL2 Liguria, Savona, Italy

    Ezio Venturino

  29. IARC-WHO, Lione, France

    Iacopo Baussano

  30. Istituto Europeo di Oncologia IRCCS, Milano, Italy

    Anna Daniela Iacobone & Eleonora Petra Preti

Authors
  1. Silvia Gori
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  2. Francesco Venturelli
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  3. Francesca Carozzi
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  4. Paolo Giorgi Rossi
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  5. Annarosa Del Mistro
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Consortia

on behalf of the Multisocietal Contributor Group

  • Tiziano Maggino
  • , Roberta Giornelli
  • , Paolo Cristoforoni
  • , Giovanni Negri
  • , Antonella Pellegrini
  • , Maggiorino Barbero
  • , Filippo Murina
  • , Emanuele Torri
  • , Franco Maria Buonaguro
  • , Paola Mantellini
  • , Anna Iossa
  • , Paola Garutti
  • , Anna Gillio Tos
  • , Annarosa Del Mistro
  • , Paolo Giorgi Rossi
  • , Silvia Gori
  • , Francesco Venturelli
  • , Francesca Carozzi
  • , Elena Allia
  • , Barbara Aguiari
  • , Karin Louise Andersson
  • , Paola Armaroli
  • , Maria Benevolo
  • , Simonetta Bisanzi
  • , Annalisa Brozzetti
  • , Simonetta Bulletti
  • , Elena Burroni
  • , Filippo Cellai
  • , Elena Cesarini
  • , Lucia Ciccocioppo
  • , Clementina Cocuzza
  • , Laura De Marco
  • , Prassede Foxi
  • , Helena Frayle
  • , Concetta Fumia
  • , Paola Garutti
  • , Daniela Gustinucci
  • , Vincenzo Maccallini
  • , Luigia Macrì
  • , Marianna Martinelli
  • , Serena Matarese
  • , Valeria Nofrini
  • , Basilio Passamonti
  • , Tiziana Rotondo
  • , Cristina Sani
  • , Priscilla Sassoli de Bianchi
  • , Maria Lina Tornesello
  • , Ezio Venturino
  • , Carmen Beatriz Visioli
  • , Iacopo Baussano
  • , Marco Zappa
  • , Anna Daniela Iacobone
  •  & Eleonora Petra Preti

Contributions

TM, RG, PC, GN, AP, MB, FM, ET, FMB, PM, AI, PG (as Technical Scientific Committee members or additional collaborators at the start of the guidelines project) conceived the guidelines, defined the scope, and prioritised the Health Questions in each chapter. ADM, PGR, FC (as chair or co-chairs) defined the protocol for literature reviews and modelling. SG, FV (as Evidence Review Team members) conducted the research, extracted the data, and filled the Sof and EtD for plenary sessions. ADM, PGR, SG, FV, FC edited the draft recommendations after plenary sessions and made changes to take into account the reviewers’ comments. ADM cured the contacts with the Italian National guideline system, submitted and got approved the recommendations. EA, BA, KLA, PA, MB, SB, AB, SB, EB, FC, EC, LC, CC, LDM, PF, HF, CF, PG, DG, VM, LM, MM, SM, VN, BP, TR, CS, PSdB, MLT, EV, CBV (as panel members) participated in prioritisation of outcome and framing of PICOs, took an active part in the plenary sessions, voted or agreed to each criteria, reviewed the draft recommendations and approved the final version after review. LDM also conceived the reported chapter of the guidelines. IB, MZ (as external reviewers) revised the review and modelling protocol. IB, MZ, ADI, and EPP (as external reviewers) reviewed the draft of the recommendations, asking for integrations and clarifications. PGR, FV, ADM, and SG drafted and edited the manuscript; FC edited the manuscript. All contributed to the final version of the guidelines and fulfilled the criteria for contributors according to the ICMJE criteria. All the authors and contributors read and approved the final version of the manuscript and agreed with its submission to the journal. ADM, as corresponding author, confirms to have read the Nature journal policies on author responsibilities and is submitting the manuscript in accordance with those policies.

Corresponding author

Correspondence to Annarosa Del Mistro.

Ethics declarations

Competing interests

SG, FV, FC, and ADM have disclosed no conflicts of interest; PGR participated in the preparation of the IARC Handbook 18 on cervical screening. COIs were collected from all the Contributor Group members. Overall, seven members disclosed potential conflicts of interest and these COIs are included in the final document published on the database of the Italian National System of Guidelines (SNLG) of the National Institute of Health (ISS) (Sistema Nazionale Linee Guida, Istituto Superiore di Sanità): https://www.iss.it/documents/20126/8403884/LG_197_GISCi_Biomarcatori-screening-cervicale_29ago24.pdf/40999ebc-246c-fe99-d483-4da375d9f76a?t=1724836991806. The Technical Scientific Committee members judged as “potentially relevant” those of three members; they were allowed full participation in the vote, with COI public disclosure.

Ethics approval and consent to participate

Not applicable. The guideline development project has been submitted to and approved by the Italian National System of Guidelines (SNLG) of the National Institute of Health (ISS) (Sistema Nazionale Linee Guida, Istituto Superiore di Sanità) https://snlg.iss.it/.

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Gori, S., Venturelli, F., Carozzi, F. et al. Italian guidelines for cervical cancer screening. Multisocietal recommendations on the use of biomarkers in HPV screening with risk-based approach and GRADE methodology. Br J Cancer (2025). https://doi.org/10.1038/s41416-025-03161-8

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