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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04856423

Enrollment

6000

Registered

2021-04-23

Start date

2021-04-19

Completion date

2023-06-30

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasm

Keywords

Colorectal Neoplasm, Occult Bleeding, Quantitative fecal immunochemical test, Colorectal Cancer, Adenoma

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.

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.

Interventions

DIAGNOSTIC_TESTThe us-qFIT and colonoscopy with pathological examination

Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The accuracy of us-qFIT to diagnose colorectal advanced adenoma.	24 months	The sensitivity, specificity, positive predictive value and negative predictive value.

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactRuchen Zhou, MD

sdlwzrc@126.com15949702165

Backup ContactYueyue Li, PhD

lyynqj@126.com18560089751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026