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

NCT ID: NCT05232721

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-20

Study Completion Date

2022-04-20

Brief Summary

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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

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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

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Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Fecal Immunochemical Test

People in this group will detect hemoglobin in stool before colonoscopy by the new instrument

The new instrument and colonoscopy with pathological examination

Intervention Type DIAGNOSTIC_TEST

Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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);
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li yanqing, Professor

Role: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

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Qilu Hospital

Jinan, Shandong, China

Site Status

Countries

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China

Central Contacts

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Song yihao, BD

Role: CONTACT

15098739370

Zhou ruchen, MD

Role: CONTACT

15949702165

Facility Contacts

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Song yihao, BD

Role: primary

15098739370

Other Identifiers

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2022SDU-QILU-105

Identifier Type: -

Identifier Source: org_study_id

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