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

September 8, 2021 updated by: Yanqing Li, Shandong University

Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yueyue Li, PhD
  • Phone Number: 18560089751
  • Email: lyynqj@126.com

Study Locations

  • China
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Binzhou Medical University Hospotal
        • Contact:
          • Chengxia Liu
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Yanqing Li
      • Jinan, Shandong, China, 250012
        • Recruiting
        • People's Hospital of Lixia District of Jinan
        • Contact:
          • Hongjun LiZhang
          • Phone Number: +8613515415912
      • Weihai, Shandong, China
        • Recruiting
        • Weihai Municipal Hospital
        • Contact:
          • Xiaozhong Gao
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Tongji Hospital, Tongji University School of Medicine
        • Contact:
          • Shuzhang Xu
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Bangmao Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from the 5 hospitals were enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Us-qFIT group
People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
Time Frame: 24 months
The sensitivity, specificity, positive predictive value and negative predictive value.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of us-qFIT to diagnose colorectal cancer.
Time Frame: 24 months
The sensitivity, specificity, positive predictive value and negative predictive value.
24 months
The accuracy of us-qFIT to diagnose high-risk adenoma.
Time Frame: 24 months
The sensitivity, specificity, positive predictive value and negative predictive value.
24 months
Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.
Time Frame: 24 months
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history, diet and so on.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Tianjin Medical University General Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Weihai Municipal Hospital
Binzhou Medical University
People's Hospital of Lixia District of Jinan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Anticipated)

April 19, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020SDU-QILU-1026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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