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

NCT01767870 | Unknown Phase 4

• 1 other identifier: CR312033
• Study Type: interventional
• Target: 5,282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Adenoma

Keywords

advanced colorectal adenoma; colonoscopy; sigmoidoscopy; fecal immunochemical test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Sensitivity of fecal immunochemical test for advanced colorectal adenoma

  on 7days after intervention

• Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

  on 7 days after intervention

• Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

  on 7 days after intervention

• positive predictive valueof fecal immunochemical test for advanced colorectal adenoma

  on 7days after intervention

• specificity of fecal immunochemical test for advanced colorectal adenoma

  on 7days after intervention

Other Outcomes (5)

• Adenoma detection rate and sessile serrated polyp detection rate

  on 7 days after intervention

• Missing adenoma rate of sigmoidoscopy

  on 7 days after intervention

• The characteristic of polyps which would be missed by sigmoidoscopy

  on 7 days after intervention

Study Arms (2)

FIT-Sigmoidoscopy

EXPERIMENTAL

This arm (FIT-Sigmoidoscopy) will take fecal immunochemical test (FIT) followed by sigmoidoscopy for evaluation of advanced colorectal adenoma detection rate. Immediately after sigmoidoscopy, a total colonoscopy will be performed as a standard method for advanced colorectal adenoma detection.

Procedure: FIT-sigmoidoscopy

Colonoscopy

EXPERIMENTAL

This arm (Colonoscopy) will take a total colonoscopy as a control group that will represent the efficacy of colonoscopy for advanced colorectal adenoma detection rate.

Procedure: Colonoscopy

Interventions

FIT-sigmoidoscopy PROCEDURE

Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy

Also known as: FITS, sigmoidoscopy

FIT-Sigmoidoscopy

Colonoscopy PROCEDURE

Advanced colorectal adenoma detection by colonoscopy

Colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic subjects aged 45 - 75 years
• Subjects who will give the written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Wonju Christian Hospital

Wŏnju, 220-701, South Korea

RECRUITING

Related Publications (8)

• 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. doi: 10.1056/NEJM200011303432203.

  PMID: 11096167 RESULT

• 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 neoplasms. Aliment Pharmacol Ther. 2009 Feb 15;29(4):450-7. doi: 10.1111/j.1365-2036.2008.03898.x. Epub 2008 Nov 17.

  PMID: 19035980 RESULT

• 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 Chinese population. Cancer. 2003 May 15;97(10):2420-4. doi: 10.1002/cncr.11369.

  PMID: 12733140 RESULT

• 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 Jun 20;115(3):493-6. doi: 10.1002/ijc.20921.

  PMID: 15700317 RESULT

• 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. doi: 10.7326/0003-4819-149-9-200811040-00245. Epub 2008 Oct 6.

  PMID: 18838718 RESULT

• 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, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

  PMID: 22612596 RESULT

• 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. doi: 10.1056/NEJMoa010328.

  PMID: 11529208 RESULT

• 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. Epub 2009 May 6.

  PMID: 19426835 RESULT

Related 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

MeSH Terms

Interventions

Sigmoidoscopy; Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hyun-Soo Kim, M.D., ph D.

  Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea

  STUDY CHAIR

• Hong Jun Park, M.D.

  Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea

  STUDY DIRECTOR

• Hwang Choi, M.D., ph D.

  Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea

  PRINCIPAL INVESTIGATOR

• Jeong Seon Ji, M.D.

  Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea

  PRINCIPAL INVESTIGATOR

• Young Suk Cho, M.D.

  Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea

  PRINCIPAL INVESTIGATOR

• Young-Eun Joo, M.D., ph D.

  Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea

  PRINCIPAL INVESTIGATOR

• Jeong Eun Shin, M.D.

  Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea

  PRINCIPAL INVESTIGATOR

• Eun Soo Kim, M.D.

  Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea

  PRINCIPAL INVESTIGATOR

• Seong-Eun Kim, M.D.

  Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Dong Il Park, M.D., ph D.

  Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Jae Myung Cha, M.D., ph D.

  Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea

  PRINCIPAL INVESTIGATOR

• Sung Noh Hong, M.D.

  Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Seun-Ja Park, M.D., ph D.

  Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea

  PRINCIPAL INVESTIGATOR

• Hyun Gun Kim, M.D.

  Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Sung Pil Hong, M.D.

  Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

• Jae Hak Kim, M.D.

  Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Soo Kim, M.D., ph D.

CONTACT

+82-33-741-1224; hyskim@yonsei.ac.kr

Hong Jun Park, M.D.

CONTACT

+82-33-741-1226; ppakongs@daum.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 14, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

KR (1)