Clinical trial NCT05200611: Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening
Official title: Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenoma
Keywords: Colorectal Adenoma
Occult Bleeding
Quantitative fecal immunochemical test
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: The People's Hospital of Zhaoyuan City
name: Shanghe People's Hospital
First posted: 2022-01-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria were enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The efficacy of fecal immunochemical test to detect advanced adenoma
timeFrame: 6 months
Secondary outcomes:
measure: The efficacy of fecal immunochemical test to detect colorectal cancer
timeFrame: 6 month
measure: The efficacy of fecal immunochemical test to detect colorectal neoplasms
timeFrame: 6 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shanghe People's Hospital
state: Shandong
city: Yantai
country: China
facility: The People's Hospital of Zhaoyuan City
state: Shandong
Study officials:
References: