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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04856423

Collaborator

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

6,000

Enrollment

Locations

26.3

Anticipated Duration (Months)

1000

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasm	Diagnostic Test: The us-qFIT and colonoscopy with pathological examination

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 Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 19, 2021

Anticipated Primary Completion Date :

Apr 19, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

The accuracy of us-qFIT to diagnose colorectal advanced adenoma. [24 months]
The sensitivity, specificity, positive predictive value and negative predictive value.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Binzhou Medical University Hospotal	Binzhou	Shandong	China
2	People's Hospital of Lixia District of Jinan	Jinan	Shandong	China	250012
3	Qilu Hospital of Shandong University	Jinan	Shandong	China
4	Weihai Municipal Hospital	Weihai	Shandong	China
5	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai	Shanghai	China
6	Tianjin Medical University General Hospital	Tianjin	Tianjin	China