Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial

详细信息    查看全文

• 作者：Daniele Regge (1)
  Gabriella Iussich (1)
  Carlo Senore (2)
  Loredana Correale (3)
  Cesare Hassan (4)
  Alberto Bert (3)
  Stefania Montemezzi (5)
  Nereo Segnan (2)
  
• 关键词：Colorectal cancer ; Screening ; Flexible sigmoidoscopy ; CT colonography ; Computer ; aided detection
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：294 KB
• 参考文献：1. Ferlay J, Parkin D, Steliarova-Foucher E: Estimates of cancer incidence and mortality in Europe in 2008. / Eur J Cancer 2010, 46:765鈥?81. CrossRef
  2. Crocetti E, Buzzoni C, AIRTUM Working Group: New incidence and mortality data, 2003鈥?005. / Epidemiol Prev 2009,33(Suppl 1鈥?):e1鈥?. e5鈥?6
  3. Winawer SJ, Zauber AG, Ho MN, O鈥橞rien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, Ackroyd F, Shike M, Kurtz RC, Hornsby-Lewis L, Gerdes H, Stewart ET: Prevention of colorectal cancer by colonoscopic polypectomy. / N Engl J Med 1993, 329:1977鈥?981. CrossRef
  4. Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM: Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. / Lancet 1996, 348:1472鈥?477. CrossRef
  5. Kronborg O, Fenger C, Olsen J, J酶rgensen OD, S酶ndergaard O: Randomised study of screening for colorectal cancer with faecal-occult-blood test. / Lancet 1996, 348:1467鈥?471. CrossRef
  6. Selby JV, Friedman GD, Quesenberry CP, Weiss NS: A case control study of screening sigmoidoscopy and mortality from colorectal cancer. / N Engl J Med 1992, 326:653鈥?57. CrossRef
  7. Newcomb PA, Norfleet RG, Storer BE, Surawicz TS, Marcus PM: Screening sigmoidoscopy and colorectal cancer mortality. / J Natl Cancer Inst 1992, 84:1572鈥?575. CrossRef
  8. Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F: Reducing Mortality from Colorectal Cancer by Screening for Fecal Occult Blood. / N Engl J Med 1993, 328:1365鈥?371. CrossRef
  9. Segnan N, Armaroli P, Bonelli L, Risio M, Sciallero S, Zappa M, Andreoni B, Arrigoni A, Bisanti L, Casella C, Crosta C, Falcini F, Ferrero F, Giacomin A, Giuliani O, Santarelli A, Visioli CB, Zanetti R, Atkin WS, Senore C, the SCORE Working Group: Once-Only Sigmoidoscopy in colorectal cancer screening: follow-up findings of the Italian randomized controlled trial, GSCORE. / J Natl Cancer Inst 2011, 103:1310鈥?322. CrossRef
  10. Lansdorp-Vogelaar I, Van Ballegooijen M, Zauber AG, Habbema JDF, Kuipers EJ: Effect of rising chemotherapy costs on the cost savings of colorectal cancer screening. / J Natl Cancer Inst 2009, 101:1412鈥?422. CrossRef
  11. Mandel JS, Church TR, Ederer F, Bond JH: Colorectal cancer mortality: effectiveness of biennial screening for fecal occult blood. / J Natl Cancer Inst 1999, 91:434鈥?37. CrossRef
  12. Van Rossum LG, Van Rijn AF, Laheij RJ, Van Oijen MG, Fockens P, Van Krieken HH, Verbeek AL, Jansen JB, Dekker E: Random Comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. / Gastroenterology 2008, 135:82鈥?0. http://www.sciencedirect.com/science/article/pii/S0016508508004782 CrossRef
  13. Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J: Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. / Lancet 2010, 375:1624鈥?633. CrossRef
  14. Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O鈥橞rien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD: Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. / N Engl J Med 2012, 366:2345鈥?357. CrossRef
  15. Hoff G, Grotmol T, Skovlund E, Bretthauer M, Norwegian Colorectal Cancer Prevention Study Group: Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial. / BMJ 2009, 338:b1846. CrossRef
  16. Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ, Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps: A joint guideline from the American cancer society, the US Multi-society task force on colorectal cancer, and the American college of radiology. / Gastroenterology 2008, 134:1570鈥?595. CrossRef
  17. Lieberman DA, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, Chejfec G, Campbell DR, Durbin TE, Bond JH, Nelson DB, Ewing SL, Triadafilopoulos G, Ramirez FC, Lee JG, Collins JF, Fennerty MB, Johnston TK, Corless CL, McQuaid KR, Garewal H, Sampliner RE, Morales TG, Fass R, Smith RE, Maheshwari Y, Weiss DG: One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon. / N Engl J Med 2001, 345:555鈥?60. CrossRef
  18. Sung JJ, Chan FK, Leung WK, Wu JC, Lau JY, Ching J, To KF, Lee YT, Luk YW, Kung NN, Kwok SP, Li MK, Chung S: Screening for colorectal cancer in Chinese: Comparison of fecal occult blood test, flexible sigmoidoscopy, and colonoscopy. / Gastroenterology 2003, 124:608鈥?14. CrossRef
  19. Anderson WF, Guyton KZ, Hiatt RA, Vernon SW, Levin B, Hawk E: Colorectal cancer screening for persons at average risk. / J Natl Cancer Inst 2002, 94:1126鈥?133. CrossRef
  20. Brenner H, Chang-Claude J, Seiler CM, Sturmer T, Hoffmeister M: Potential for colorectal cancer prevention of sigmoidoscopy versus colonoscopy: population-based case control study. / Cancer Epidemiol Biomarkers Prev 2007, 16:494鈥?99. CrossRef
  21. Rabeneck L, Lewis JD, Paszat LF, Saskin R, Stukel TA: Risk of proximal and distal colorectal cancer following flexible sigmoidoscopy: a population-based cohort study. / Am J Gastroenterol 2008, 103:2075鈥?082. CrossRef
  22. Pickhardt PJ, Hassan C, Halligan S, Marmo R: Colorectal cancer: CT Colonography and colonoscopy for detection-systematic review and meta-analysis. / Radiology 2011, 259:393鈥?05. CrossRef
  23. Pickhardt PJ, Choi JR, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, Wong RK, Nugent PA, Mysliwiec PA, Schindler WR: Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. / N Engl J Med 2003, 349:2191鈥?200. CrossRef
  24. Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ: Accuracy of CT Colonography for detection of large adenomas and cancers. / N Engl J Med 2008, 359:1207鈥?217. CrossRef
  25. Stoop EM, De Haan MC, De Wijkerslooth TR, Bossuyt PM, Van Ballegooijen M, Nio CY, van de Vijver MJ, Biermann K, Thomeer M, Van Leerdam ME, Fockens P, Stoker J, Kuipers EJ, Dekker E: Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial. / Lancet Oncol 2012, 13:55鈥?4. CrossRef
  26. Liedenbaum M, Vries A, Rijn A, Dekker H, Willemssen F, Leerdam M, Marrewijk C, Fockens P, Bipat S, Bossuyt P, Dekker E, Stoker J: CT colonography with limited bowel preparation for the detection of colorectal neoplasia in an FOBT positive screening population. / Abdom Imaging 2010, 35:661鈥?68. CrossRef
  27. Pickhardt PJ: Incidence of colonic perforation at CT Colonography: review of existing data and implications for screening of asymptomatic adults. / Radiology 2006, 239:313鈥?16. CrossRef
  28. Burling D, Halligan S, Slater A, Noakes MJ, Taylor SA: Potentially Serious Adverse Events at CT Colonography in Symptomatic Patients: National Survey of the United Kingdom. / Radiology 2006, 239:464鈥?71. CrossRef
  29. Sosna J, Blachar A, Amitai M, Barmeir E, Peled N, Goldberg SN, Bar-Ziv J: Colonic Perforation at CT colonography: assessment of risk in a multicenter large cohort. / Radiology 2006, 239:457鈥?63. CrossRef
  30. Iafrate F, Iussich G, Correale L, Hassan C, Regge D, Neri E, Baldassari P, Ciolina M, Pichi A, Iannitti M, Diacinti D, Laghi A: Adverse events of computed tomography colonography: an Italian national survey. / Dig Liver Dis 2013, 35:661鈥?68.
  31. Florie J, Gelder R, Schutter M, Randen A, Venema H, Jager S, Hulst V, Prent A, Bipat S, Bossuyt P, Baak L, Stoker J: Feasibility study of computed tomography colonography using limited bowel preparation at normal and low-dose levels study. / Eur Radiol 2007, 17:3112鈥?122. CrossRef
  32. Jensch S, Bipat S, Peringa J, Vries A, Heutinck A, Dekker E, Baak L, Montauban Van Swijndregt A, Stoker J: CT colonography with limited bowel preparation: prospective assessment of patient experience and preference in comparison to optical colonoscopy with cathartic bowel preparation. / Eur Radiol 2010, 20:146鈥?56. CrossRef
  33. Pickhardt PJ, Hassan C, Laghi A, Zullo A, Kim DH, Morini S: Cost-effectiveness of colorectal cancer screening with computed tomography colonography. / Cancer 2007, 109:2213鈥?221. CrossRef
  34. Hassan C, Zullo A, Laghi A, Reitano I, Taggi F, Cerro P, Iafrate F, Giustini M, Winn S, Morini S: Colon cancer prevention in Italy: Cost-effectiveness analysis with CT colonography and endoscopy. / Dig Liver Dis 2007, 39:242鈥?50. CrossRef
  35. Hassan C, Pickhardt PJ: Cost-effectiveness of CT colonography. / Radiol Clin North Am 2013, 51:89鈥?7. CrossRef
  36. Pickhardt PJ, Taylor AJ: Extracolonic findings identified in asymptomatic adults at screening CT colonography. / AJR Am J Roentgenol 2006, 186:718鈥?28. CrossRef
  37. Zalis ME, Barish MA, Choi JR, Dachman AH, Fenlon HM, Ferrucci JT, Glick SN, Laghi A, Macari M, McFarland EG, Morrin MM, Pickhardt PJ, Soto J, Yee J, the Working Group on Virtual Colonoscopy F: CT Colonography Reporting and Data System: a consensus proposal. / Radiology 2005, 236:3鈥?. CrossRef
  38. Hassan C, Pickhardt PL, Laghi A, Kim DH, Zullo A, Iafrate F, Di Giulio L, Morini S: Computed tomographic colonography to screen for colorectal cancer, extracolonic cancer, and aortic aneurysm: Model simulation with cost-effectiveness analysis. / Arch Intern Med 2008, 168:696鈥?05. CrossRef
  39. Pickhardt PJ, Hanson ME, Vanness DJ, Lo JY, Kim DH, Taylor AJ, Winter TC, Hinshaw JL: Unsuspected extracolonic findings at screening CT colonography: clinical and economic impact. / Radiology 2008, 249:151鈥?59. CrossRef
  40. Sali L, Grazzini G, Carozzi F, Castiglione G, Falchini M, Mallardi B, Mantellini P, Ventura L, Regge D, Zappa M, Mascalchi M, Milani S: Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study). / Trials 2013, 14:74. CrossRef
  41. Doshi T, Rusinak D, Halvorsen RA, Rockey DC, Suzuki K, Dachman AH: CT colonography: false-negative interpretations. / Radiology 2007, 244:165鈥?73. CrossRef
  42. Heresbach D, Djabbari M, Riou F, Marcus C, Le Sidaner A, Pierredon-Foulogne MA, Ponchon T, Boudiaf M, Seyrig JA, Laumonier H, Luet D, Giraud-Cohen M, Pelletier AL, Charachon A, Ramaholimihaso F, Bouillet P, Veyrac M, Ficarelli S, Vahedi K, Keruhel J, Lamouliatte H, Ridereau-Zins C, Bouhnik Y, Tissier M, Diris B, Zagdanski AM, Josselin JM, Hamonic S, Gandon Y: Accuracy of computed tomographic colonography in a nationwide multicentre trial, and its relation to radiologist expertise. / Gut 2011, 60:658鈥?65. CrossRef
  43. Regge D, Hassan C, Pickhardt PJ, Laghi A, Zullo A, Kim DH, Iafrate F, Morini S: Impact of computer-aided detection on the cost-effectiveness of CT colonography. / Radiology 2009, 250:488鈥?97. CrossRef
  44. Regge D, Monica PD, Galatola G, Laudi C, Zambon A, Correale L, Asnaghi R, Barbaro B, Borghi C, Campanella D, Cassinis MC, Ferrari R, Ferraris A, Hassan C, Iafrate F, Iussich G, Laghi A, Massara R, Neri E, Sali L, Venturini S, Gandini G: Efficacy of computer-aided detection as a second reader for 6鈥? mm lesions at CT colonography: multicenter prospective trial. / Radiology 2013, 266:168鈥?76. CrossRef
  45. Halligan S, Mallett S, Altman DG, McQuillan J, Proud M, Beddoe G, Honeyfield L, Taylor SA: Incremental benefit of computer-aided detection when used as a second and concurrent reader of CT colonographic data: multiobserver study. / Radiology 2011, 258:469鈥?76. CrossRef
  46. Dachman AH, Obuchowski NA, Hoffmeister JW, Hinshaw JL, Frew MI, Winter TC, Van Uitert RL, Periaswamy S, Summers RM, Hillman BJ: Effect of Computer-aided Detection for CT Colonography in a Multireader, Multicase Trial. / Radiology 2010, 256:827鈥?35. CrossRef
  47. Taylor SA, Charman SC, Lefere P, McFarland EG, Paulson EK, Yee J, Aslam R, Barlow JM, Gupta A, Kim DH, Miller CM, Halligan S: CT colonography: investigation of the optimum reader paradigm by using computer-aided detection software. / Radiology 2008, 246:463鈥?71. CrossRef
  48. Mani A, Napel S, Paik D Jr, Jeffrey R, Yee J, Olcott E, Prokesch R, Davila M, Schraedley-Desmond P, Beaulieu C: Computed tomography colonography: feasibility of computer-aided polyp detection in a first-reader paradigm. / J Comput Assist Tomogr 2004, 28:318鈥?32. CrossRef
  49. Robinson C, Halligan S, Iinuma G, Topping W, Punwani S, Honeyfield L, Taylor SA: CT colonography: computer-assisted detection of colorectal cancer. / Br J Radiol 2011, 84:435鈥?40. CrossRef
  50. Iussich G, Correale L, Senore C, Segnan N, Laghi A, Iafrate F, Campanella D, Neri E, Cerri F, Hassan C, Regge D: CT colonography: preliminary assessment of a double-read paradigm that uses computer-aided detection as the first reader. / Radiology 2013, 268:743鈥?51. CrossRef
  51. Iussich G, Correale L, Senore C, Segnan N, Campanella D, Galatola G, Laudi C, Regge D: Computer Aided Detection (CAD) for CT Colonography Screening: a Prospective Comparison of a Double Reading Paradigm with First Reader CAD Against Second Reader CAD. / Invest Radiol in press
  52. Campanella D, Morra L, Delsanto S, Tartaglia V, Asnaghi R, Bert A, Neri E, Regge D: Comparison of three different iodine-based bowel regimens for CT colonography. / Eur Radiol 2010, 20:348鈥?58. CrossRef
  53. Segnan N, Senore C, Andreoni B, Azzoni A, Bisanti L, Cardelli A, Castiglione G, Crosta C, Ederle A, Fantin A, Ferrari A, Fracchia M, Ferrero F, Gasperoni S, Recchia S, Risio M, Rubeca T, Saracco G, Zappa M: Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening. / Gastroenterology 2007, 132:2304鈥?312. CrossRef
  54. Jass JR, Sobin LH: / Histological typing of intestinal tumors. second edition. New York: Springer-Verlag; 1989. CrossRef
  55. Senore C, Ederle A, Fantin A, Andreoni B, Bisanti L, Grazzini G, Zappa M, Ferrero F, Marutti A, Giuliani O, Armaroli P, Segnan N: Acceptability and side-effects of colonoscopy and sigmoidoscopy in a screening setting. / J Med Screen 2011, 18:128鈥?34. CrossRef
  56. Senore C, Armaroli P, Silvani M, Andreoni B, Bisanti L, Castiglione G, Grazzini G, Taddei S, Gasperoni S, Giuliani O, Malfitana G, Marutti A, Genta G, Segnan N: Comparing Different strategies for colorectal cancer screening in Italy: predictors of patients鈥?participation. / Am J Gastroenterol 2009, 105:188鈥?98. CrossRef
  57. Zorzi M, Falcini F, Grazzini G, De鈥橞ianchi P, Senore C, Vettorazzi M, Visioli C, Zappa M: Screening for colorectal cancer in Italy: 2006 survey. / Epidemiol Prev 2006, 32:55鈥?8.
  58. Prentice RL: Surrogate endpoints in clinical trials: Definition and operational criteria. / Stat Med 1989, 8:431鈥?40. CrossRef
  59. Hassan C, Pickhardt P, Marmo R, Choi J: Impact of lifestyle factors on colorectal polyp detection in the screening setting. / Dis Colon Rectum 2010, 53:1328鈥?333. CrossRef
  60. Wilmink A, Quick C, Hubbard C, Day N: Effectiveness and cost of screening for abdominal aortic aneurysm: results of a population screening program. / J Vasc Surg 2003, 38:72鈥?7. CrossRef
  
• 作者单位：Daniele Regge (1)
  Gabriella Iussich (1)
  Carlo Senore (2)
  Loredana Correale (3)
  Cesare Hassan (4)
  Alberto Bert (3)
  Stefania Montemezzi (5)
  Nereo Segnan (2)
  
  1. Radiology Unit, Institute for Cancer Research and Treatment, FPO, Strada Provinciale 142, Candiolo, 10060, Italy
  2. CPO Piemonte and AO 鈥楥ity of Health and Science,鈥?SC Epidemiologia dei Tumori, Turin, Italy
  3. im3D SpA, Turin, Italy
  4. Department of Radiological Sciences Oncology and Pathology, University of Rome La Sapienza, Rome, Italy
  5. Radiology Unit, Azienda Ospedaliera di Verona, Verona, Italy
  
• ISSN：1745-6215

文摘

Background Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening. Methods/Design An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected. Discussion This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting. Trial registration ClinicalTrials.gov Identifier: NCT01739608