NCT04856423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

April 19, 2021

Last Update Submit

September 8, 2021

Conditions

Colorectal Neoplasm

Keywords

Colorectal NeoplasmOccult BleedingQuantitative fecal immunochemical testColorectal CancerAdenoma

Outcome Measures

Primary Outcomes (1)

  • The accuracy of us-qFIT to diagnose colorectal advanced adenoma.

    The sensitivity, specificity, positive predictive value and negative predictive value.

    24 months

Secondary Outcomes (3)

  • The accuracy of us-qFIT to diagnose colorectal cancer.

    24 months

  • The accuracy of us-qFIT to diagnose high-risk adenoma.

    24 months

  • Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.

    24 months

Study Arms (1)

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

Interventions

The us-qFIT and colonoscopy with pathological examinationDIAGNOSTIC_TEST

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

Us-qFIT group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from the 5 hospitals were enrolled.

You may qualify if:

  • years old people;
  • People sign an "informed consent form"

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Binzhou Medical University Hospotal

Binzhou, Shandong, China

RECRUITING

People's Hospital of Lixia District of Jinan

Jinan, Shandong, 250012, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, China

RECRUITING

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Yanqing Li, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Ruchen Zhou, MD

CONTACT

15949702165sdlwzrc@126.com

Yueyue Li, PhD

CONTACT

18560089751lyynqj@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

April 19, 2021

Primary Completion

April 19, 2023

Study Completion

June 30, 2023

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(6)