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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05232721
Enrollment
275
Registered
2022-02-10
Start date
2022-02-20
Completion date
2022-04-20
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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).

Interventions

DIAGNOSTIC_TESTThe 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.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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);

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance of advanced neoplasms4 monthsThe 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

MeasureTime frameDescription
Diagnostic performance of Colorectal Cancer4 monthsThe 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

Countries

China

Contacts

Primary ContactSong yihao, BD
1019038804@qq.com15098739370
Backup ContactZhou ruchen, MD
sdlwzrc@126.com15949702165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026