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JNCI Journal of the National Cancer Institute 2005 97(5):347-357; doi:10.1093/jnci/dji050
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© 2005 Oxford University Press

ARTICLE

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 Rizzetto, Giorgio Saracco, Mauro Spandre, Delio Turco, Patricia Turco, Marco Zappa, SCORE2 Working Group–Italy

Affiliations of authors: Centro Prevenzione Oncologica Regione Piemonte and Azienda Sanitaria Ospedaliera S Giovanni Battista, Torino, Italy (NS, CS); Surgery Unit II, Istituto Europeo di Oncologia, Milano, Italy (BA); Gastroenterology Unit, Azienda Sanitaria Ospedaliera S Giovanni Battista, S Giovanni Antica Sede Hospital, Torino, Italy (AA, MS); Epidemiology Unit, Azienda Sanitaria Locale "Citta' di Milano", Milano, Italy (LB); Gastroenterology Unit, Infermi Hospital, Azienda Unità Sanitaria Locale Rimini, Rimini, Italy (AC, SG); Gastroenterology Unit, Centro Studio Prevenzione Oncologica, Firenze, Italy (GC); Gastroenterology Unit, Istituto Europeo di Oncologia, Milano, Italy (CC); Gastroenterology Unit, S Giovanni Bosco Hospital, Torino, Italy (RD, SR); Gastroenterology Unit, Maria Vittoria Hospital, Torino, Italy (AF, DT); Gastroenterology Unit, Mauriziano "Umberto I" Hospital, Torino, Italy (RF, MF); Gastroenterology Unit, Infermi Hospital, Azienda Sanitaria Locale 12, Biella, Italy (FF, GM); Pathology Unit, Istituto per la Ricerca e la Cura del Cancro, Candiolo, Torino, Italy (M. Risio); Gastroenterology Unit, Azienda Sanitaria Ospedaliera S Giovanni Battista-Molinette Hospital , Torino, Italy (M. Rizzetto, GS); Citopathology Unit, Centro Studio Prevenzione Oncologica, Firenze, Italy (PT); Clinical Epidemiology Unit, Centro Studio Prevenzione Oncologica, Firenze, Italy (MZ)

Correspondence to: Nereo Segnan, MD, MS, EpiUnita' di Epidemiologia, CPO Piemonte, ASO "S Giovanni Battista," Via S Francesco da Paola 31, 10123 Turin, Italy (e-mail: nereo.segnan{at}cpo.it).

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 28 319 people sampled, 1637 were excluded and 26 682 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% (3049/10 867), 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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Editorial about this Article

Offering Patients Colorectal Cancer Screening
Timothy R. Church
J Natl Cancer Inst 2005 97: 328-329. [Extract] [Full Text] [PDF]



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