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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 71 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings