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Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy
  1. Carlo Senore1,
  2. Marco Zappa2,
  3. Cinzia Campari3,
  4. Sergio Crotta4,
  5. Paola Armaroli1,
  6. Arrigo Arrigoni5,
  7. Paola Cassoni6,
  8. Rossana Colla3,
  9. Mario Fracchia7,
  10. Fabrizio Gili8,
  11. Grazia Grazzini9,
  12. Roberto Lolli10,
  13. Patrizia Menozzi3,
  14. Lorenzo Orione11,
  15. Salvatore Polizzi12,
  16. Stefano Rapi13,
  17. Emilia Riggi1,
  18. Tiziana Rubeca9,
  19. Romano Sassatelli3,
  20. Carmen Visioli2,
  21. Nereo Segnan1
  1. 1 SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
  2. 2 Clinical Epidemiology Unit, ISPRO, Florence, Italy
  3. 3 Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
  4. 4 AUSL Valle d'Aosta, Aosta, Italy
  5. 5 University Gastroenterology Unit, Ospedale San Giovanni Antica Sede, Turin, Italy
  6. 6 Department of Medical Sciences, Universita degli Studi di Torino, Turin, Italy
  7. 7 Gastroenterology Unit, Mauriziano Umberto I Hospital, Turin, Italy
  8. 8 Colorectal Cancer Screening Laboratory, University Hospital Città della Salute e della Scienza, Turin, Italy
  9. 9 Screening Unit, ISPRO, Florence, Italy
  10. 10 Gastroenterology Unit, Regional Hospital, Aosta, Italy
  11. 11 Screening Unit, ASL CN1, Cuneo, Italy
  12. 12 Screening Unit, ASL TO5, Moncalieri, Italy
  13. 13 Laboratory, Careggi Hospital, Florence, Italy
  1. Correspondence to Dr Carlo Senore, SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin 10123, Italy; carlo.senore{at}


Objective To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer—CRC—or advanced adenoma).

Design Prospective cohort of subjects aged 50–69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy.

Methods All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method.

Results The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels.

Conclusion The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

  • FIT
  • CRC screening
  • advanced adenoma

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  • Correction notice This article has been corrected since it published Online First. The author affiliations have been amended.

  • Contributors Study concept and design: CS, MZ, NS and GG. Acquisition of data: AA, CV, FG, LO, MF, PC, PM, RC, RL, SC, SP, RS. Analysis and interpretation of data: CS, MZ, NS, CC, GG, TR and SR. Drafting of the manuscript: CS, TR, SR, CV and CC. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: CS, PA and ER. Study supervision: NS, MZ and CS.

  • Funding The study was conducted in the context of the routine monitoring activity of programmes performance.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request.

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