Proteiomic Fingerprints of Gastric Juice
November 3, 2015 updated by: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kaohsiung, Taiwan, 813
- Kaohsiung Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: gastric cancer
gastric cancer patients
|
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Names:
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Names:
|
|
Active Comparator: normal subject
healthy subject
|
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Names:
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Accurate Diagnosis for Gastric Cancer
Time Frame: 2 months
|
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
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ping-I Hsu, M.D., Kaohsiung Veterans Genaral hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
February 2, 2009
First Submitted That Met QC Criteria
February 2, 2009
First Posted (Estimate)
February 3, 2009
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
November 3, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGHKS96-CT2-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.