Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Adenoma
• Intervention / Treatment: Diagnostic test: Fecal Immunochemical Test

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Ruchen Zhou; Phone Number: +8615949702165; Email: sdlwzrc@126.com
• Study Contact Backup: Name: Yanqing Li; Phone Number: +8618560087666; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Not yet recruiting
      • Shanghe People's Hospital
    • Yantai, Shandong, China
      • Recruiting
      • The People's Hospital of Zhaoyuan City
      • Contact: Shihuan Wang; Phone Number: +8613562589535

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria were enrolled.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fecal Immunochemical Test; People in this group with positive fecal immunochemical test results were further examined by colonoscopy.	Diagnostic test: Fecal Immunochemical Test; Participants with positive fecal immunochemical test results were further examined by colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of fecal immunochemical test to detect advanced adenoma	The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of fecal immunochemical test to detect colorectal cancer	The detection rate and positive predictive value of fecal immunochemical test to detect colorectal cancer	6 month
The efficacy of fecal immunochemical test to detect colorectal neoplasms	The detection rate and positive predictive value of fecal immunochemical test to detect colorectal neoplasms	6 month

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: The People's Hospital of Zhaoyuan City; Shanghe People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Adenoma; Occult Bleeding; Quantitative fecal immunochemical test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 2022SDU-QILU-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No