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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Colorectal Adenoma

Treatments: Procedure: Colonoscopy; Procedure: FIT-sigmoidoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01767870

CR312033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,282 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,282 participants in 2 patient groups

FIT-Sigmoidoscopy

Experimental group

Description:

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.

Treatment:

Procedure: FIT-sigmoidoscopy

Colonoscopy

Experimental group

Description:

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.

Treatment:

Procedure: Colonoscopy