A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening

NCT04454099 | Completed

• 1 other identifier: 2020SDU-QILU-524
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; fecal occult blood testing; quantitative fecal immunochemical test

Outcome Measures

Primary Outcomes (4)

• The accuracy of 4 kind of FOBTs to diagnose CRC.

  The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.

  6 months

• The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.

  The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.

  6 months

• The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.

  The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.

  6 months

• Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.

  Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.

  6 months

Secondary Outcomes (3)

• Explore the cost-benefit ratio of one or two-sample of qFIT.

  6 month

• Explore the reason of false positive of qFIT

  6 month

• Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT

  6 month

Study Arms (1)

Fecal Occult Blood Test

People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy.

Diagnostic Test: 4 kind of FOBT and colonoscopy with pathological examination

Interventions

4 kind of FOBT and colonoscopy with pathological examination DIAGNOSTIC_TEST

Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.

Fecal Occult Blood Test

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adults 50-75 years old;
• Asia-Pacific Colorectal Screening score(APCS): medium or high risk.

You may not qualify if:

• APCS score: low risk;
• People with history of intestinal surgery;
• People with history of CRC;
• People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
• People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
• Pregnancy, lactation or menstrual phase;
• Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250001, China

Location

Related Publications (1)

• Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.

  PMID: 27769517 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yanqing Li, PhD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

CN (1)