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

  • Taiwan
      • 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
Other: normal subject
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Names:
  • biomarker in gastric juice
Other: gastric cancer
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Names:
  • biomarker in gastric juice
Active Comparator: normal subject
healthy subject
Other: normal subject
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Names:
  • biomarker in gastric juice
Other: gastric cancer
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Names:
  • biomarker in gastric juice

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.

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

National Science Council, Taiwan

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.

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