A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT04473677

Collaborator

(none)

1,600

Enrollment

Location

9.8

Actual Duration (Months)

163.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared with existing commercially available qFIT, is developed and this study will prove the high diagnostic accuracy in detecting colorectal advanced adenoma.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Adenoma Colorectal Neoplasm Colorectal Cancer	Diagnostic Test: The new qFIT and colonoscopy with pathological examination

Detailed Description

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. 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 of colonoscopy. Conversely, stool tests are relatively cheap and more readily accepted. Annual fecal immunochemical test (FIT), one of the preferred methods of colorectal cancer screening, is economic and easy to use. However, the existing commercially available qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve diagnostic accuracy in detecting colorectal advanced adenoma, an improved technology of qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin in stool compared with existing commercially available qFIT, is developed. The investigators design this research to prove the diagnostic accuracy of the new qFIT in detecting colorectal advanced adenoma.

Study Design

Study Type:

Observational

Actual Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A New Quantitative Fecal Immunochemical Test Can Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma.

Actual Study Start Date :

Aug 17, 2020

Actual Primary Completion Date :

Jun 11, 2021

Actual Study Completion Date :

Jun 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Fecal Occult Blood Test People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.	Diagnostic Test: The new qFIT and colonoscopy with pathological examination Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

Arm

Intervention/Treatment

Fecal Occult Blood Test

People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.

Diagnostic Test: The new qFIT and colonoscopy with pathological examination

Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.

Outcome Measures

Primary Outcome Measures

The accuracy of the new qFIT to diagnose colorectal advanced adenoma. [18 months]
The sensitivity, specificity, positive predictive value and negative predictive value.

Secondary Outcome Measures

The accuracy of the new qFIT to diagnose colorectal cancer. [18 months]
The sensitivity, specificity, positive predictive value and negative predictive value.
Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT. [18 months]
Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT, age , sex, colorectal cancer 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 surgery in any part of the large bowel;
People with history of colorectal cancer;
People with history of other diseases that may produce fecal blood, such as active diverticulitis, inflammatory bowel disease, ischemic enteritis, vascular malformation 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 7th type stool (Bristol feces score);
People are in pregnancy, lactation or menstrual phase;
People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.