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

Multi-center Application Study of Quantitative FIT Technology for Colorectal Cancer Screening in Chinese Physical Examination Population

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Screening Fecal Immunochemical Test
• Intervention / Treatment: Device: Quantitative Fecal Immunochemical Test (qFIT)

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.

• Study Type: Observational
• Enrollment (Anticipated): 500000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Yingying Yu, Dr; Phone Number: +8613588413860; Email: yuyingying@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy physical examination person over 30 years of age

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of quantitative FIT	The sensitivity of quantitative FIT application in Chinese physical examination population	1year
Specificity of quantitative FIT	The specificity of quantitative FIT application in Chinese physical examination population	1year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Peking Union Medical College Hospital; Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; Tongji Hospital; Guangdong Provincial People's Hospital; Shenzhen People's Hospital; The First Hospital of Jilin University; Wuhan Union Hospital, China; Renmin Hospital of Wuhan University; Xinqiao Hospital of Chongqing; First Hospital of China Medical University; The First Hospital of Hebei Medical University; Bethune International Peace Hospital; Second Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; The Second Hospital of Anhui Medical University; The Second Affiliated Hospital of Dalian Medical University; The Second Hospital of Nanjing Medical University; Jiangsu Provincial People's Hospital; The First Affiliated Hospital of Inner Mongolia Medical College; Jiangxi Provincial People's Hopital; First Affiliated Hospital of Suzhou Medical College; Sino-Japanese Friendship Hospital of Jilin University; The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2018-181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No