Randomized trial of different screening strategies for colorectal cancer: Patient response and detection rates

Nereo Segnan, Carlo Senore, Bruno Andreoni, Arrigo Arrigoni, Luigi Bisanti, Alessandro Cardelli, Guido Castiglione, Cristiano Crosta, Roberta DiPlacido, Arnaldo Ferrari, Roberto Ferraris, Franco Ferrero, Mario Fracchia, Stefano Gasperoni, Giuseppe Malfitana, Serafino Recchia, Mauro Risio, Mario Rizetto, Giorgio Saracco, Mauro SpandreDelio Turco, Patricia Turco, Marco Zappa, Angelo Penna, Alberto Azzoni, Francesco Decembrino, Mauro Giudici, Giovanna Genta, Anna Marutti, Grazia Grazzini, Serena Taddei, Massimo Confortini, Tiziana Rubeca, Cristina Sani, Luca Messerini, Giancarla Fiori, Luisa Marai, Stefano Bargiggia, Cristina Gerosa, Roberto Penagini, Zenia Pirone, Alfredo Rossi, Edi Viale, Orietta Giuliani, Paolo Rinaldi, Alberto Bertone, Mariella Cavallero, Marco Pennazio, Tatiana Sprujevnik, Esther Berardengo, Angelo Pera, Franco Copolla, Giovanni Galatola, Marco Tabone, Antionetta Garripoli, Alessandra Mondardini, Paolo Martinoglio, Paola Secreto, Stefano Taraglio, Edoardo Formento, Alessandro Repici, Paola Cassoni, Maurizio Cosimato, Marco Silvani, Daniela Brunetti, Rosa Amerio, Marco Dalmasso

Research output: Contribution to journalArticle

162 Citations (Scopus)

Abstract

Background: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We compared the participation and detection rates achievable through different strategies of colorectal cancer screening. Methods: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55-64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (≤2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or "once-only" sigmoidoscopy, 4) "once-only" sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. Results: Of 28319 people sampled, 1637 were excluded and 26682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1% (682/2266), 28.1% (1654/5893), 27.1% (970/3579), 28.1% (1026/3650), and 28.1% (3049/10867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3%) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4%) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6%) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1%) harbored an advanced adenoma. Conclusions: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.

Original languageEnglish
Pages (from-to)347-357
Number of pages11
JournalJournal of the National Cancer Institute
Volume97
Issue number5
DOIs
Publication statusPublished - Mar 2 2005

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Occult Blood
Hematologic Tests
Sigmoidoscopy
Colorectal Neoplasms
Adenoma
Early Detection of Cancer
General Practitioners
Logistic Models
Postal Service
Colonoscopy
Inflammatory Bowel Diseases
Italy
Endoscopy
Multicenter Studies
Consensus

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Segnan, N., Senore, C., Andreoni, B., Arrigoni, A., Bisanti, L., Cardelli, A., ... Dalmasso, M. (2005). Randomized trial of different screening strategies for colorectal cancer: Patient response and detection rates. Journal of the National Cancer Institute, 97(5), 347-357. https://doi.org/10.1093/jnci/dji050

Randomized trial of different screening strategies for colorectal cancer : Patient response and detection rates. / Segnan, Nereo; Senore, Carlo; Andreoni, Bruno; Arrigoni, Arrigo; Bisanti, Luigi; Cardelli, Alessandro; Castiglione, Guido; Crosta, Cristiano; DiPlacido, Roberta; Ferrari, Arnaldo; Ferraris, Roberto; Ferrero, Franco; Fracchia, Mario; Gasperoni, Stefano; Malfitana, Giuseppe; Recchia, Serafino; Risio, Mauro; Rizetto, Mario; Saracco, Giorgio; Spandre, Mauro; Turco, Delio; Turco, Patricia; Zappa, Marco; Penna, Angelo; Azzoni, Alberto; Decembrino, Francesco; Giudici, Mauro; Genta, Giovanna; Marutti, Anna; Grazzini, Grazia; Taddei, Serena; Confortini, Massimo; Rubeca, Tiziana; Sani, Cristina; Messerini, Luca; Fiori, Giancarla; Marai, Luisa; Bargiggia, Stefano; Gerosa, Cristina; Penagini, Roberto; Pirone, Zenia; Rossi, Alfredo; Viale, Edi; Giuliani, Orietta; Rinaldi, Paolo; Bertone, Alberto; Cavallero, Mariella; Pennazio, Marco; Sprujevnik, Tatiana; Berardengo, Esther; Pera, Angelo; Copolla, Franco; Galatola, Giovanni; Tabone, Marco; Garripoli, Antionetta; Mondardini, Alessandra; Martinoglio, Paolo; Secreto, Paola; Taraglio, Stefano; Formento, Edoardo; Repici, Alessandro; Cassoni, Paola; Cosimato, Maurizio; Silvani, Marco; Brunetti, Daniela; Amerio, Rosa; Dalmasso, Marco.

In: Journal of the National Cancer Institute, Vol. 97, No. 5, 02.03.2005, p. 347-357.

Research output: Contribution to journalArticle

Segnan, N, Senore, C, Andreoni, B, Arrigoni, A, Bisanti, L, Cardelli, A, Castiglione, G, Crosta, C, DiPlacido, R, Ferrari, A, Ferraris, R, Ferrero, F, Fracchia, M, Gasperoni, S, Malfitana, G, Recchia, S, Risio, M, Rizetto, M, Saracco, G, Spandre, M, Turco, D, Turco, P, Zappa, M, Penna, A, Azzoni, A, Decembrino, F, Giudici, M, Genta, G, Marutti, A, Grazzini, G, Taddei, S, Confortini, M, Rubeca, T, Sani, C, Messerini, L, Fiori, G, Marai, L, Bargiggia, S, Gerosa, C, Penagini, R, Pirone, Z, Rossi, A, Viale, E, Giuliani, O, Rinaldi, P, Bertone, A, Cavallero, M, Pennazio, M, Sprujevnik, T, Berardengo, E, Pera, A, Copolla, F, Galatola, G, Tabone, M, Garripoli, A, Mondardini, A, Martinoglio, P, Secreto, P, Taraglio, S, Formento, E, Repici, A, Cassoni, P, Cosimato, M, Silvani, M, Brunetti, D, Amerio, R & Dalmasso, M 2005, 'Randomized trial of different screening strategies for colorectal cancer: Patient response and detection rates', Journal of the National Cancer Institute, vol. 97, no. 5, pp. 347-357. https://doi.org/10.1093/jnci/dji050
Segnan, Nereo ; Senore, Carlo ; Andreoni, Bruno ; Arrigoni, Arrigo ; Bisanti, Luigi ; Cardelli, Alessandro ; Castiglione, Guido ; Crosta, Cristiano ; DiPlacido, Roberta ; Ferrari, Arnaldo ; Ferraris, Roberto ; Ferrero, Franco ; Fracchia, Mario ; Gasperoni, Stefano ; Malfitana, Giuseppe ; Recchia, Serafino ; Risio, Mauro ; Rizetto, Mario ; Saracco, Giorgio ; Spandre, Mauro ; Turco, Delio ; Turco, Patricia ; Zappa, Marco ; Penna, Angelo ; Azzoni, Alberto ; Decembrino, Francesco ; Giudici, Mauro ; Genta, Giovanna ; Marutti, Anna ; Grazzini, Grazia ; Taddei, Serena ; Confortini, Massimo ; Rubeca, Tiziana ; Sani, Cristina ; Messerini, Luca ; Fiori, Giancarla ; Marai, Luisa ; Bargiggia, Stefano ; Gerosa, Cristina ; Penagini, Roberto ; Pirone, Zenia ; Rossi, Alfredo ; Viale, Edi ; Giuliani, Orietta ; Rinaldi, Paolo ; Bertone, Alberto ; Cavallero, Mariella ; Pennazio, Marco ; Sprujevnik, Tatiana ; Berardengo, Esther ; Pera, Angelo ; Copolla, Franco ; Galatola, Giovanni ; Tabone, Marco ; Garripoli, Antionetta ; Mondardini, Alessandra ; Martinoglio, Paolo ; Secreto, Paola ; Taraglio, Stefano ; Formento, Edoardo ; Repici, Alessandro ; Cassoni, Paola ; Cosimato, Maurizio ; Silvani, Marco ; Brunetti, Daniela ; Amerio, Rosa ; Dalmasso, Marco. / Randomized trial of different screening strategies for colorectal cancer : Patient response and detection rates. In: Journal of the National Cancer Institute. 2005 ; Vol. 97, No. 5. pp. 347-357.
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abstract = "Background: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We compared the participation and detection rates achievable through different strategies of colorectal cancer screening. Methods: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55-64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (≤2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or {"}once-only{"} sigmoidoscopy, 4) {"}once-only{"} sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. Results: Of 28319 people sampled, 1637 were excluded and 26682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1{\%} (682/2266), 28.1{\%} (1654/5893), 27.1{\%} (970/3579), 28.1{\%} (1026/3650), and 28.1{\%} (3049/10867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3{\%}) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4{\%}) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6{\%}) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1{\%}) harbored an advanced adenoma. Conclusions: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.",
author = "Nereo Segnan and Carlo Senore and Bruno Andreoni and Arrigo Arrigoni and Luigi Bisanti and Alessandro Cardelli and Guido Castiglione and Cristiano Crosta and Roberta DiPlacido and Arnaldo Ferrari and Roberto Ferraris and Franco Ferrero and Mario Fracchia and Stefano Gasperoni and Giuseppe Malfitana and Serafino Recchia and Mauro Risio and Mario Rizetto and Giorgio Saracco and Mauro Spandre and Delio Turco and Patricia Turco and Marco Zappa and Angelo Penna and Alberto Azzoni and Francesco Decembrino and Mauro Giudici and Giovanna Genta and Anna Marutti and Grazia Grazzini and Serena Taddei and Massimo Confortini and Tiziana Rubeca and Cristina Sani and Luca Messerini and Giancarla Fiori and Luisa Marai and Stefano Bargiggia and Cristina Gerosa and Roberto Penagini and Zenia Pirone and Alfredo Rossi and Edi Viale and Orietta Giuliani and Paolo Rinaldi and Alberto Bertone and Mariella Cavallero and Marco Pennazio and Tatiana Sprujevnik and Esther Berardengo and Angelo Pera and Franco Copolla and Giovanni Galatola and Marco Tabone and Antionetta Garripoli and Alessandra Mondardini and Paolo Martinoglio and Paola Secreto and Stefano Taraglio and Edoardo Formento and Alessandro Repici and Paola Cassoni and Maurizio Cosimato and Marco Silvani and Daniela Brunetti and Rosa Amerio and Marco Dalmasso",
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TY - JOUR

T1 - Randomized trial of different screening strategies for colorectal cancer

T2 - Patient response and detection rates

AU - Segnan, Nereo

AU - Senore, Carlo

AU - Andreoni, Bruno

AU - Arrigoni, Arrigo

AU - Bisanti, Luigi

AU - Cardelli, Alessandro

AU - Castiglione, Guido

AU - Crosta, Cristiano

AU - DiPlacido, Roberta

AU - Ferrari, Arnaldo

AU - Ferraris, Roberto

AU - Ferrero, Franco

AU - Fracchia, Mario

AU - Gasperoni, Stefano

AU - Malfitana, Giuseppe

AU - Recchia, Serafino

AU - Risio, Mauro

AU - Rizetto, Mario

AU - Saracco, Giorgio

AU - Spandre, Mauro

AU - Turco, Delio

AU - Turco, Patricia

AU - Zappa, Marco

AU - Penna, Angelo

AU - Azzoni, Alberto

AU - Decembrino, Francesco

AU - Giudici, Mauro

AU - Genta, Giovanna

AU - Marutti, Anna

AU - Grazzini, Grazia

AU - Taddei, Serena

AU - Confortini, Massimo

AU - Rubeca, Tiziana

AU - Sani, Cristina

AU - Messerini, Luca

AU - Fiori, Giancarla

AU - Marai, Luisa

AU - Bargiggia, Stefano

AU - Gerosa, Cristina

AU - Penagini, Roberto

AU - Pirone, Zenia

AU - Rossi, Alfredo

AU - Viale, Edi

AU - Giuliani, Orietta

AU - Rinaldi, Paolo

AU - Bertone, Alberto

AU - Cavallero, Mariella

AU - Pennazio, Marco

AU - Sprujevnik, Tatiana

AU - Berardengo, Esther

AU - Pera, Angelo

AU - Copolla, Franco

AU - Galatola, Giovanni

AU - Tabone, Marco

AU - Garripoli, Antionetta

AU - Mondardini, Alessandra

AU - Martinoglio, Paolo

AU - Secreto, Paola

AU - Taraglio, Stefano

AU - Formento, Edoardo

AU - Repici, Alessandro

AU - Cassoni, Paola

AU - Cosimato, Maurizio

AU - Silvani, Marco

AU - Brunetti, Daniela

AU - Amerio, Rosa

AU - Dalmasso, Marco

PY - 2005/3/2

Y1 - 2005/3/2

N2 - Background: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We compared the participation and detection rates achievable through different strategies of colorectal cancer screening. Methods: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55-64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (≤2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or "once-only" sigmoidoscopy, 4) "once-only" sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. Results: Of 28319 people sampled, 1637 were excluded and 26682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1% (682/2266), 28.1% (1654/5893), 27.1% (970/3579), 28.1% (1026/3650), and 28.1% (3049/10867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3%) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4%) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6%) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1%) harbored an advanced adenoma. Conclusions: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.

AB - Background: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We compared the participation and detection rates achievable through different strategies of colorectal cancer screening. Methods: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55-64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (≤2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or "once-only" sigmoidoscopy, 4) "once-only" sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. Results: Of 28319 people sampled, 1637 were excluded and 26682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1% (682/2266), 28.1% (1654/5893), 27.1% (970/3579), 28.1% (1026/3650), and 28.1% (3049/10867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3%) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4%) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6%) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1%) harbored an advanced adenoma. Conclusions: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.

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