NCT00834236

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 7, 2015

Completed
Last Updated

December 7, 2015

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

February 2, 2009

Results QC Date

September 30, 2015

Last Update Submit

November 3, 2015

Conditions

Keywords

gastric cancerproteomicsgastric juice

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

EXPERIMENTAL

gastric cancer patients

Other: normal subjectOther: gastric cancer

normal subject

ACTIVE COMPARATOR

healthy subject

Other: normal subjectOther: gastric cancer

Interventions

biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA

Also known as: biomarker in gastric juice
gastric cancernormal subject

biomarker in gastric juice, e.g., alpha 1-antitrypsin

Also known as: biomarker in gastric juice
gastric cancernormal subject

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

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

  • Ping-I Hsu, M.D.

    Kaohsiung Veterans Genaral hospital

    PRINCIPAL INVESTIGATOR

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

Locations