Back to resultsProteiomic Fingerprints of Gastric Juice
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
normal subject
gastric cancer
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastric cancer, proteomics, gastric juice
Eligibility Criteria
Inclusion Criteria:
- healthy subjects and gastric cancer patients documented by endoscopy.
Exclusion Criteria:
- the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
- coexistence of two kinds of gastroduodenal lesions
- coexistence of severe systemic diseases
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
gastric cancer
normal subject
Arm Description
gastric cancer patients
healthy subject
Outcomes
Primary Outcome Measures
Number of Participants With Accurate Diagnosis for Gastric Cancer
Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice
Secondary Outcome Measures
Full Information
NCT ID
NCT00834236
First Posted
February 2, 2009
Last Updated
November 3, 2015
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00834236
Brief Title
Proteiomic Fingerprints of Gastric Juice
Official Title
Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
No accurate, inexpensive and non-invasive test for gastric cancer screening is currently available. The investigators' recent study identified a1-antitrypsin and other proteins as potential biomarkers of gastric cancer in gastric juice. The aim of this study was to develop a novel non-invasive modality for detecting gastric cancer by measurement of biomarkers in gastric juice.
Detailed Description
Patients and methods: The study consisted of two parts: (1) investigating the differences in gastric juice biomarker concentrations between gastric cancer patients and controls, and (2) screening gastric cancer using string test to obtain gastric juice followed by immunoassay for biomarker concentration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, proteomics, gastric juice
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gastric cancer
Arm Type
Experimental
Arm Description
gastric cancer patients
Arm Title
normal subject
Arm Type
Active Comparator
Arm Description
healthy subject
Intervention Type
Other
Intervention Name(s)
normal subject
Other Intervention Name(s)
biomarker in gastric juice
Intervention Description
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Intervention Type
Other
Intervention Name(s)
gastric cancer
Other Intervention Name(s)
biomarker in gastric juice
Intervention Description
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Primary Outcome Measure Information:
Title
Number of Participants With Accurate Diagnosis for Gastric Cancer
Description
Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects and gastric cancer patients documented by endoscopy.
Exclusion Criteria:
the use of proton pump inhibitors or histamine-2 receptor antagonists within 4 weeks prior to the study
coexistence of two kinds of gastroduodenal lesions
coexistence of severe systemic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-I Hsu, M.D.
Organizational Affiliation
Kaohsiung Veterans Genaral hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
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Proteiomic Fingerprints of Gastric Juice
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