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

Shandong University

Status

Unknown

Conditions

Colorectal Cancer

Treatments

Diagnostic Test: The new instrument and colonoscopy with pathological examination

Study type

Observational

Funder types

Other

Identifiers

NCT05232721

2022SDU-QILU-105

Details and patient eligibility

About

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) .

Full 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).

Enrollment

275 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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);