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

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: The new instrument and colonoscopy with pathological examination

• Registration Number: NCT05232721
• Lead Sponsor: Shandong University

Brief 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).

Study Timeline

• Study First Submitted: 2022-01-06
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10
• Study Start: 2022-02-20
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• People who use the new instrument for fecal immunochemical test(FIT)
• People sign an "informed consent form"

Exclusion Criteria

• People with history of surgery in any part of the large bowel;
• People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fecal Immunochemical Test	The new instrument and colonoscopy with pathological examination	People in this group will detect hemoglobin in stool before colonoscopy by the new instrument

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of advanced neoplasms	4 months	The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of Colorectal Cancer	4 months	The study is committed to test the diagnostic efficacy of the new instrument to colorectal cancer.We will measure the sensitivity and specificity of the instrument

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China