Proteiomic Fingerprints of Gastric Juice
Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
1 other identifier
interventional
76
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable gastric-cancer
Started Mar 2008
Typical duration for not_applicable gastric-cancer
2 active sites
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
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
December 7, 2015
CompletedDecember 7, 2015
September 1, 2015
3 years
February 2, 2009
September 30, 2015
November 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 months
Study Arms (2)
gastric cancer
EXPERIMENTALgastric cancer patients
normal subject
ACTIVE COMPARATORhealthy subject
Interventions
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Eligibility Criteria
You may qualify if:
- healthy subjects and gastric cancer patients documented by endoscopy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was performed in a single country
Results Point of Contact
- Title
- Dr. Ping-I Hsu
- Organization
- Kaohsiung Veterans General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Ping-I Hsu, M.D.
Kaohsiung Veterans Genaral hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
March 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 7, 2015
Results First Posted
December 7, 2015
Record last verified: 2015-09