A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma
1 other identifier
observational
1,600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedStudy Start
First participant enrolled
August 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedJune 18, 2021
June 1, 2021
10 months
July 14, 2020
June 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The accuracy of the new qFIT to diagnose colorectal advanced adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value.
18 months
Secondary Outcomes (2)
The accuracy of the new qFIT to diagnose colorectal cancer.
18 months
Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT.
18 months
Study Arms (1)
Fecal Occult Blood Test
People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.
Interventions
Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.
Eligibility Criteria
Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from Qilu Hospital were enrolled.
You may qualify if:
- years old people;
- People sign an "informed consent form"
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital
Jinan, Shandong, 250001, China
Biospecimen
stool samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yanqing Li, PhD
Qilu Hospital of Shandong University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 16, 2020
Study Start
August 17, 2020
Primary Completion
June 11, 2021
Study Completion
June 11, 2021
Last Updated
June 18, 2021
Record last verified: 2021-06