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

Carlo Senore, Marco Zappa, Cinzia Campari, Sergio Crotta, Paola Armaroli, Arrigo Arrigoni, Paola Cassoni, Rossana Colla, Mario Fracchia, Fabrizio Gili, Grazia Grazzini, Roberto Lolli, Patrizia Menozzi, Lorenzo Orione, Salvatore Polizzi, Stefano Rapi, Emilia Riggi, Tiziana Rubeca, Romano Sassatelli, Carmen VisioliNereo Segnan

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Abstract

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.

Original languageEnglish
JournalGut
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Italy
Hemoglobins
Prospective Studies
Population
Neoplasms
Feces
Logistic Models
Population Control
Colonoscopy
Adenoma
Endoscopy
Colorectal Neoplasms
Japan

Keywords

  • advanced adenoma
  • CRC screening
  • FIT

ASJC Scopus subject areas

  • Gastroenterology

Cite this

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. / Senore, Carlo; Zappa, Marco; Campari, Cinzia; Crotta, Sergio; Armaroli, Paola; Arrigoni, Arrigo; Cassoni, Paola; Colla, Rossana; Fracchia, Mario; Gili, Fabrizio; Grazzini, Grazia; Lolli, Roberto; Menozzi, Patrizia; Orione, Lorenzo; Polizzi, Salvatore; Rapi, Stefano; Riggi, Emilia; Rubeca, Tiziana; Sassatelli, Romano; Visioli, Carmen; Segnan, Nereo.

In: Gut, 01.01.2019.

Research output: Contribution to journalArticle

Senore, C, Zappa, M, Campari, C, Crotta, S, Armaroli, P, Arrigoni, A, Cassoni, P, Colla, R, Fracchia, M, Gili, F, Grazzini, G, Lolli, R, Menozzi, P, Orione, L, Polizzi, S, Rapi, S, Riggi, E, Rubeca, T, Sassatelli, R, Visioli, C & Segnan, N 2019, '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', Gut. https://doi.org/10.1136/gutjnl-2018-318198
Senore, Carlo ; Zappa, Marco ; Campari, Cinzia ; Crotta, Sergio ; Armaroli, Paola ; Arrigoni, Arrigo ; Cassoni, Paola ; Colla, Rossana ; Fracchia, Mario ; Gili, Fabrizio ; Grazzini, Grazia ; Lolli, Roberto ; Menozzi, Patrizia ; Orione, Lorenzo ; Polizzi, Salvatore ; Rapi, Stefano ; Riggi, Emilia ; Rubeca, Tiziana ; Sassatelli, Romano ; Visioli, Carmen ; Segnan, Nereo. / 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. In: Gut. 2019.
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title = "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",
abstract = "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.",
keywords = "advanced adenoma, CRC screening, FIT",
author = "Carlo Senore and Marco Zappa and Cinzia Campari and Sergio Crotta and Paola Armaroli and Arrigo Arrigoni and Paola Cassoni and Rossana Colla and Mario Fracchia and Fabrizio Gili and Grazia Grazzini and Roberto Lolli and Patrizia Menozzi and Lorenzo Orione and Salvatore Polizzi and Stefano Rapi and Emilia Riggi and Tiziana Rubeca and Romano Sassatelli and Carmen Visioli and Nereo Segnan",
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issn = "0017-5749",
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TY - JOUR

T1 - Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds

T2 - A prospective study in the context of population based screening programmes in Italy

AU - Senore, Carlo

AU - Zappa, Marco

AU - Campari, Cinzia

AU - Crotta, Sergio

AU - Armaroli, Paola

AU - Arrigoni, Arrigo

AU - Cassoni, Paola

AU - Colla, Rossana

AU - Fracchia, Mario

AU - Gili, Fabrizio

AU - Grazzini, Grazia

AU - Lolli, Roberto

AU - Menozzi, Patrizia

AU - Orione, Lorenzo

AU - Polizzi, Salvatore

AU - Rapi, Stefano

AU - Riggi, Emilia

AU - Rubeca, Tiziana

AU - Sassatelli, Romano

AU - Visioli, Carmen

AU - Segnan, Nereo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - advanced adenoma

KW - CRC screening

KW - FIT

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U2 - 10.1136/gutjnl-2018-318198

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