Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

• Conditions: Colorectal Neoplasms; Colorectal Adenoma; Colorectal Cancer
• Interventions: Diagnostic Test: Fecal Immunochemical Test

• Registration Number: NCT05200611
• Lead Sponsor: Shandong University

Brief Summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Detailed Description

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study Start: 2022-01-04
• Study First Submitted QC: 2022-01-16
• Last Update Submitted: 2022-01-16
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Adults 50-75 years old

Exclusion Criteria

• People with history of intestinal surgery;
• People with history of colorectal cancer;
• People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
• People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea;
• Pregnancy, lactation or menstrual phase;
• Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fecal Immunochemical Test	Fecal Immunochemical Test	People in this group with positive fecal immunochemical test results were further examined by colonoscopy.

Primary Outcome Measures

Name	Time	Method
The efficacy of fecal immunochemical test to detect advanced adenoma	6 months	The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma

Secondary Outcome Measures

Name	Time	Method
The efficacy of fecal immunochemical test to detect colorectal cancer	6 month	The detection rate and positive predictive value of fecal immunochemical test to detect colorectal cancer
The efficacy of fecal immunochemical test to detect colorectal neoplasms	6 month	The detection rate and positive predictive value of fecal immunochemical test to detect colorectal neoplasms

Trial Locations

Locations (2)

Shanghe People's Hospital; 🇨🇳 Jinan, Shandong, China

The People's Hospital of Zhaoyuan City; 🇨🇳 Yantai, Shandong, China