A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Neoplasm; Colorectal Adenoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250001
      • Qilu hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 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 Qilu Hospital were enrolled.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of the new qFIT to diagnose colorectal advanced adenoma.	The sensitivity, specificity, positive predictive value and negative predictive value.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of the new qFIT to diagnose colorectal cancer.	The sensitivity, specificity, positive predictive value and negative predictive value.	18 months
Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT.	Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT, age , sex, colorectal cancer family history, diet and so on.	18 months

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2020
• Primary Completion (ACTUAL): June 11, 2021
• Study Completion (ACTUAL): June 11, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma; quantitative fecal immunochemical test; Occult Bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 2020SDU-QILU-708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No