Clinical trial NCT04959617: Multi-center Application of Quantitative FIT Technology in Colorectal Cancer Screening
Official title: Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Screening Fecal Immunochemical Test
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
name: The Second Hospital of Anhui Medical University
name: The First Hospital of Jilin University
name: Sino-Japanese Friendship Hospital of Jilin University
name: First Hospital of China Medical University
name: The First Affiliated Hospital of Dalian Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: The Second Hospital of Hebei Medical University
name: The First Hospital of Hebei Medical University
name: Jiangsu Provincial People's Hospital
name: The Second Hospital of Nanjing Medical University
name: Jiangxi Provincial People's Hopital
name: Second Affiliated Hospital of Nanchang University
name: First Affiliated Hospital of Harbin Medical University
name: Peking Union Medical College Hospital
name: Shenzhen People's Hospital
name: Guangdong Provincial People's Hospital
name: Tongji Hospital
name: First Affiliated Hospital of Suzhou Medical College
name: Chinese PLA General Hospital
name: Wuhan Union Hospital, China
name: The First Affiliated Hospital of Inner Mongolia Medical College
name: Bethune International Peace Hospital
name: Xinqiao Hospital of Chongqing
name: Renmin Hospital of Wuhan University
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
First posted: 2021-07-13
Enrollment: 500000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy physical examination person over 30 years of age

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of quantitative FIT
timeFrame: 1year
measure: Specificity of quantitative FIT
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: