Colorectal Cancer Screening Fecal Immunochemical Test
Conditions
Brief summary
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
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.
Interventions
DEVICEQuantitative Fecal Immunochemical Test (qFIT)
The study only included quantitative FIT examination in the general physical examination population over 30 years old.
Sponsors
The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Anhui Medical University
The First Hospital of Jilin University
Sino-Japanese Friendship Hospital of Jilin University
First Hospital of China Medical University
The First Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Dalian Medical University
The Second Hospital of Hebei Medical University
The First Hospital of Hebei Medical University
Jiangsu Provincial People's Hospital
The Second Hospital of Nanjing Medical University
Jiangxi Provincial People's Hopital
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Harbin Medical University
Peking Union Medical College Hospital
Shenzhen People's Hospital
Guangdong Provincial People's Hospital
Tongji Hospital
First Affiliated Hospital of Suzhou Medical College
Chinese PLA General Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital of Inner Mongolia Medical College
Bethune International Peace Hospital
Xinqiao Hospital of Chongqing
Renmin Hospital of Wuhan University
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of quantitative FIT | 1year | The sensitivity of quantitative FIT application in Chinese physical examination population |
| Specificity of quantitative FIT | 1year | The specificity of quantitative FIT application in Chinese physical examination population |
Countries
China
Outcome results
None listed