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Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pre-endoscopic screening risk assessment
Sponsored by
State Key Laboratory of Cancer Biology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring Gastric cancer, Screening, Risk assessment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.Age 18-60. 2.Signed informed consent

Exclusion Criteria:

  • 1.Severe back ground disease including malignancy. 2.State after gastric surgery. 3.COPD, CHF, CRF and any disease with respiratory disturbances. 4.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

  • Dake ChuRecruiting

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 early gastric cancer
Diagnostic rate of patients with early gastric cancer

Secondary Outcome Measures

Characterization of the high-rik individual for gastric cancer
Diagnostic rate of patients with early gastric cancer

Full Information

First Posted
March 25, 2018
Last Updated
April 16, 2018
Sponsor
State Key Laboratory of Cancer Biology
Collaborators
Tang-Du Hospital, Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03484949
Brief Title
Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer
Official Title
Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy for Gastric Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
April 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
Tang-Du Hospital, Xijing 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
Gastric cancer is one of the most common malignancies in China. Early detection is critical for gastric cancer management. However, the diagnosis rate of patients with early gastric cancer is still low. Therefore, the investigator design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve early gastric cancer diagnosis rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, 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 early gastric cancer
Description
Diagnostic rate of patients with early gastric cancer
Time Frame
2020
Secondary Outcome Measure Information:
Title
Characterization of the high-rik individual for gastric cancer
Description
Diagnostic rate of patients with early gastric cancer
Time Frame
2020

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: 1.Age 18-60. 2.Signed informed consent Exclusion Criteria: 1.Severe back ground disease including malignancy. 2.State after gastric surgery. 3.COPD, CHF, CRF and any disease with respiratory disturbances. 4.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
Dake Chu
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

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Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer

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