Clinical trial NCT04856423: Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer
Official title: Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasm
Keywords: Colorectal Neoplasm
Occult Bleeding
Quantitative fecal immunochemical test
Colorectal Cancer
Adenoma
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Tianjin Medical University General Hospital
name: Binzhou Medical University
name: Weihai Municipal Hospital
name: People's Hospital of Lixia District of Jinan
First posted: 2021-04-23
Enrollment: 6000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from the 5 hospitals were enrolled.

Brief summary: Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Detailed description: Early detection of CRC in a curable stage can reduce mortality but not morbidity. 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. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.

Eligibility criteria: Inclusion Criteria:

* 50-75 years old people;
* People sign an "informed consent form"

Exclusion Criteria:

* People with history of colorectal surgery;
* People with history of colorectal cancer;
* People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
* People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
* People are in pregnancy, lactation or menstrual phase;
* People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Primary outcomes:
measure: The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
timeFrame: 24 months
Secondary outcomes:
measure: The accuracy of us-qFIT to diagnose colorectal cancer.
timeFrame: 24 months
measure: The accuracy of us-qFIT to diagnose high-risk adenoma.
timeFrame: 24 months
measure: Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.
timeFrame: 24 months
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospotal
state: Shandong
city: Jinan
country: China
facility: People's Hospital of Lixia District of Jinan
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, PhD
role: STUDY_CHAIR
References: