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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200611
Other study ID # 2022SDU-QILU-103
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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