NCT05232721

Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 275 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .

Detailed description

Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The new instrument and colonoscopy with pathological examination	Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

Timeline

• Start date: 2022-02-20
• Primary completion: 2022-04-01
• Completion: 2022-04-20
• First posted: 2022-02-10
• Last updated: 2022-02-10

Locations

1 site across 1 country: China