Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200611
• Other study ID #: 2022SDU-QILU-103
• Status: Recruiting
• Start date: January 4, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2022
• Source: Shandong University
• Contact: Ruchen Zhou
• Phone: +8615949702165
• Email: sdlwzrc[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Fecal Immunochemical Test
Participants with positive fecal immunochemical test results were further examined by colonoscopy.

Locations

Country	Name	City	State
China	Shanghe People's Hospital	Jinan	Shandong
China	The People's Hospital of Zhaoyuan City	Yantai	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	Shanghe People's Hospital, The People's Hospital of Zhaoyuan City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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