NCT04856423

Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The us-qFIT and colonoscopy with pathological examination	Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

Timeline

• Start date: 2021-04-19
• Primary completion: 2023-04-19
• Completion: 2023-06-30
• First posted: 2021-04-23
• Last updated: 2021-09-16

Locations

6 sites across 1 country: China