Multi-center Application of Quantitative FIT Technology in Colorectal Cancer Screening

NCT ID: NCT04959617

Last Updated: 2021-11-09

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

500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-06

Study Completion Date

2022-12-31

Brief Summary

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In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population

Detailed Description

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Feces were collected for quantitative FIT test. Those with positive results were further examined by colonoscopy. By comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative FIT technology for the diagnosis of colorectal tumors were confirmed.

Conditions

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Colorectal Cancer Screening Fecal Immunochemical Test

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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Quantitative Fecal Immunochemical Test (qFIT)

The study only included quantitative FIT examination in the general physical examination population over 30 years old.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Healthy people aged 30 years and planning to undergo colonoscopy;
2. No history of gastrointestinal tumor;
3. No ulcerative colitis or Crohn's disease;
4. No gastrointestinal hemorrhagic disease;
5. No history of gastrointestinal surgery, able to understand and willing to sign informed consent.

Exclusion Criteria

1. Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
2. Patients with gastric and esophageal cancer and other malignant tumors;
3. Unable to cooperate after communication;
4. Subjects who have received radiotherapy and chemotherapy;
5. Other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment PI, students of the researcher, PI, affiliated research units of the co-investigator or employees of the sponsor, etc
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Sino-Japanese Friendship Hospital of Jilin University

UNKNOWN

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Jiangxi Provincial People's Hopital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Inner Mongolia Medical College

UNKNOWN

Sponsor Role collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yingying Yu, Dr

Role: primary

Other Identifiers

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2018-181

Identifier Type: -

Identifier Source: org_study_id