Proteiomic Fingerprints of Gastric Juice

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT00834236
First received: February 2, 2009
Last updated: November 3, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Gastric Cancer
Other: normal subject
Other: gastric cancer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Number of Participants With Accurate Diagnosis for Gastric Cancer [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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


Enrollment: 76
Study Start Date: March 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gastric cancer
gastric cancer patients
Other: normal subject
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Name: biomarker in gastric juice
Other: gastric cancer
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Name: biomarker in gastric juice
Active Comparator: normal subject
healthy subject
Other: normal subject
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
Other Name: biomarker in gastric juice
Other: gastric cancer
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Other Name: biomarker 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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834236

Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Science Council, Taiwan
Investigators
Principal Investigator: Ping-I Hsu, M.D. Kaohsiung Veterans Genaral hospital
  More Information

Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT00834236     History of Changes
Other Study ID Numbers: VGHKS96-CT2-24 
Study First Received: February 2, 2009
Results First Received: September 30, 2015
Last Updated: November 3, 2015
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
gastric cancer
proteomics
gastric juice

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on April 27, 2016