Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

Colorectal Adenoma Clinical Trial

— FITS  

Official title:

Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01767870
• Other study ID #: CR312033
• Status: Recruiting
• Phase: Phase 4
• First received: December 19, 2012
• Last updated: January 10, 2013
• Start date: August 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2013
• Source: Yonsei University
• Contact: Hyun-Soo Kim, M.D., ph D.
• Phone: +82-33-741-1224
• Email: hyskim[@]yonsei.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.

Description:

The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study.

Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5282
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Asymptomatic subjects aged 45 - 75 years

• Subjects who will give the written consent

Exclusion Criteria:

• Subjects with past history of colorectal cancer

• Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)

• Subjects with familial history of colorectal cancer more than 2 familial member in direct line

• Subjects with inflammatory bowel disease(IBD)

• Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification

• Subjects with past history of colectomy

• Subjects with history of colonoscopy within 5 years

• Subjects with history of sigmoidoscopy within 3 years

• Subjects with history of CT colonoscopy within 10 years

• Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Adenoma

Intervention

Procedure:
• FIT-sigmoidoscopy
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
• Colonoscopy
Advanced colorectal adenoma detection by colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	Wonju Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Kato J, Morikawa T, Kuriyama M, Yamaji Y, Wada R, Mitsushima T, Yamamoto K. Combination of sigmoidoscopy and a fecal immunochemical test to detect proximal colon neoplasia. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1341-6. doi: 10.1016/j.cgh.2009.04.025. — View Citation

Launoy GD, Bertrand HJ, Berchi C, Talbourdet VY, Guizard AV, Bouvier VM, Caces ER. Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average-risk population. Int J Cancer. 2005 J — View Citation

Lieberman DA, Weiss DG; Veterans Affairs Cooperative Study Group 380. One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon. N Engl J Med. 2001 Aug 23;345(8):555-60. — View Citation

Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000 Nov 30;343(22):1603-7. — View Citation

Rozen P, Levi Z, Hazazi R, Waked A, Vilkin A, Maoz E, Birkenfeld S, Niv Y. Quantitative colonoscopic evaluation of relative efficiencies of an immunochemical faecal occult blood test and a sensitive guaiac test for detecting significant colorectal neoplas — View Citation

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'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohag — View Citation

Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):638-58. Epub 2008 Oct 6. Review. — View Citation

Wong WM, Lam SK, Cheung KL, Tong TS, Rozen P, Young GP, Chu KW, Ho J, Law WL, Tung HM, Choi HK, Lee YM, Lai KC, Hu WH, Chan CK, Yuen MF, Wong BC. Evaluation of an automated immunochemical fecal occult blood test for colorectal neoplasia detection in a Chi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adenoma detection rate and sessile serrated polyp detection rate	We will evaluate adenoma detection rate and sessile serrated polyp detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Other	Missing adenoma rate of sigmoidoscopy	We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Other	The characteristic of polyps which would be missed by sigmoidoscopy	We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Other	Cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy.	We will evaluate the cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy on 7 days after colonoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Other	Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy	We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.	on 7 days after intervention	No
Primary	Advanced colorectal adenoma detection rate between two groups	We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	Sensitivity of fecal immunochemical test for advanced colorectal adenoma	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.	on 7days after intervention	No
Secondary	Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	positive predictive valueof fecal immunochemical test for advanced colorectal adenoma	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.	on 7days after intervention	No
Secondary	specificity of fecal immunochemical test for advanced colorectal adenoma	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.	on 7days after intervention	No
Secondary	negative predictive value of fecal immunochemical test for advanced colorectal adenoma	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.	on 7days after intervention	No
Secondary	specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No
Secondary	negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer	We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.	on 7 days after intervention	No

External Links

•   We use the web-based e-Case report form (CRF) system for collection of data from different area, named 'eVLEOS' system which servers are located on Korean National Cancer Center