Proteiomic Fingerprints of Gastric Juice

Gastric Cancer Clinical Trial

Official title:

Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834236
• Other study ID #: VGHKS96-CT2-24
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: November 3, 2015
• Start date: March 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No