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

NCT01767870 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5282

Last updated 2013-01-14

No results posted yet for this study

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

Interventions

PROCEDURE

FIT-sigmoidoscopy

Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy

PROCEDURE

Colonoscopy

Advanced colorectal adenoma detection by colonoscopy

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hyun-Soo Kim, M.D., ph D. · Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea

  • Hong Jun Park, M.D. · Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea

  • Hwang Choi, M.D., ph D. · Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea

  • Jeong Seon Ji, M.D. · Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea

  • Young Suk Cho, M.D. · Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea

  • Young-Eun Joo, M.D., ph D. · Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea

  • Jeong Eun Shin, M.D. · Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea

  • Eun Soo Kim, M.D. · Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea

  • Seong-Eun Kim, M.D. · Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea

  • Dong Il Park, M.D., ph D. · Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea

  • Jae Myung Cha, M.D., ph D. · Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea

  • Sung Noh Hong, M.D. · Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea

  • Seun-Ja Park, M.D., ph D. · Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea

  • Hyun Gun Kim, M.D. · Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea

  • Sung Pil Hong, M.D. · Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea

  • Jae Hak Kim, M.D. · Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767870 on ClinicalTrials.gov