Clinical trial NCT04454099: A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening
Official title: A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
fecal occult blood testing
quantitative fecal immunochemical test
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 1000
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 Qilu Hospital were enrolled.

Brief summary: Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.

Detailed description: Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.

Eligibility criteria: Inclusion Criteria:

* Adults 50-75 years old;
* Asia-Pacific Colorectal Screening score(APCS): medium or high risk.

Exclusion Criteria:

* APCS score: low risk;
* People with history of intestinal surgery;
* People with history of CRC;
* 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 and Bristol feces score 7th type;
* Pregnancy, lactation or menstrual phase;
* Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Primary outcomes:
measure: The accuracy of 4 kind of FOBTs to diagnose CRC.
timeFrame: 6 months
measure: The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
timeFrame: 6 months
measure: The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
timeFrame: 6 months
measure: Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
timeFrame: 6 months
Secondary outcomes:
measure: Explore the cost-benefit ratio of one or two-sample of qFIT.
timeFrame: 6 month
measure: Explore the reason of false positive of qFIT
timeFrame: 6 month
measure: Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT
timeFrame: 6 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, PhD
role: STUDY_CHAIR
References:
citation: Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.