Back to resultsWeb-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps
Primary Purpose
Colorectal Polyp
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pre-endoscopic screening risk assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Polyp focused on measuring Colorectal Polyp, Screening, Risk assessment
Eligibility Criteria
Inclusion Criteria:
- Age 18-65.
- Signed informed consent
Exclusion Criteria:
- Severe back ground disease including malignancy.
- State after gastric surgery.
- COPD, CHF, CRF and any disease with respiratory disturbances.
- Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
Sites / Locations
- State Key laboratory of Cancer BiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pre-endoscopic screening risk assessment
routine screening
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic rate of patients with polyps
Diagnostic rate of patients with polyps
Secondary Outcome Measures
Number and characteristics of polyps detected
Characterization of types of polyps
Full Information
NCT ID
NCT03750617
First Posted
March 27, 2018
Last Updated
November 20, 2018
Sponsor
State Key Laboratory of Cancer Biology
Collaborators
Xijing Hospital, Tang-Du Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03750617
Brief Title
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps
Official Title
Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy Screening of Colorectal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Cancer Biology
Collaborators
Xijing Hospital, Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyp
Keywords
Colorectal Polyp, Screening, Risk assessment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pre-endoscopic screening risk assessment
Arm Type
Experimental
Arm Title
routine screening
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
pre-endoscopic screening risk assessment
Intervention Description
pre-endoscopic screening risk assessment
Primary Outcome Measure Information:
Title
Diagnostic rate of patients with polyps
Description
Diagnostic rate of patients with polyps
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Number and characteristics of polyps detected
Description
Characterization of types of polyps
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65.
Signed informed consent
Exclusion Criteria:
Severe back ground disease including malignancy.
State after gastric surgery.
COPD, CHF, CRF and any disease with respiratory disturbances.
Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dake Chu, M.D.
Phone
86-29-85323922
Email
chudake@hotmail.com
Facility Information:
Facility Name
State Key laboratory of Cancer Biology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dake Chu, M.D.
Email
chudake@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps
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