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Proteiomic Fingerprints of Gastric Juice

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ClinicalTrials.gov Identifier: NCT00834236
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: normal subject Other: gastric cancer Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
Study Start Date : March 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834236


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Science Council, Taiwan
Investigators
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Principal Investigator: Ping-I Hsu, M.D. Kaohsiung Veterans Genaral hospital
More Information
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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT00834236    
Other Study ID Numbers: VGHKS96-CT2-24
First Posted: February 3, 2009    Key Record Dates
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015
Last Verified: September 2015
Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
gastric cancer
proteomics
gastric juice
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases