Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer

NCT ID: NCT04856423

Last Updated: 2021-09-16

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

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-19

Study Completion Date

2023-06-30

Brief Summary

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Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.

Detailed Description

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Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.

Conditions

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Colorectal Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Us-qFIT group

People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy.

The us-qFIT and colonoscopy with pathological examination

Intervention Type DIAGNOSTIC_TEST

Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

Interventions

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The us-qFIT and colonoscopy with pathological examination

Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 50-75 years old people;
* People sign an "informed consent form"

Exclusion Criteria

* People with history of colorectal surgery;
* People with history of colorectal cancer;
* People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
* People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
* People are in pregnancy, lactation or menstrual phase;
* People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Binzhou Medical University

OTHER

Sponsor Role collaborator

Weihai Municipal Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Lixia District of Jinan

UNKNOWN

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD

Role: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

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Binzhou Medical University Hospotal

Binzhou, Shandong, China

Site Status RECRUITING

People's Hospital of Lixia District of Jinan

Jinan, Shandong, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, China

Site Status RECRUITING

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ruchen Zhou, MD

Role: CONTACT

15949702165

Yueyue Li, PhD

Role: CONTACT

18560089751

Facility Contacts

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Chengxia Liu

Role: primary

Hongjun LiZhang

Role: primary

+8613515415912

Yanqing Li

Role: primary

Xiaozhong Gao

Role: primary

Shuzhang Xu

Role: primary

Bangmao Wang

Role: primary

Other Identifiers

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2020SDU-QILU-1026

Identifier Type: -

Identifier Source: org_study_id

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