Gastric CancerNCT00834236
Proteiomic Fingerprints of Gastric Juice
A study testing normal subject and gastric cancer in people with Gastric Cancer, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- normal subject and gastric cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesTaiwan
- Study dates
- Mar 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects and gastric cancer patients documented by endoscopy.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- normal subject, gastric cancer
- Keywords
- gastric cancer, proteomics, gastric juice
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal subjectOther
Also called biomarker in gastric juice
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancerOther
Also called biomarker in gastric juice
biomarker in gastric juice, e.g., alpha 1-antitrypsin
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer | Experimental | gastric cancer patients Receives: Other: normal subject; Other: gastric cancer |
| normal subject | Active comparator | healthy subject Receives: Other: normal subject; Other: gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
- Investigators
- Ping-I Hsu, M.D., Principal investigator, Kaohsiung Veterans Genaral hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834236
- Sponsor's protocol ID
- VGHKS96-CT2-24
- Status last verified
- Sep 2015
- First submitted
- 2 Feb 2009
- Last updated
- 7 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Gastroduodenal Diseases by Proteiomic Fingerprints of Gastric Juice
- ClinicalTrials.gov ID
- NCT00834236
- Acronym / sponsor ID
- VGHKS96-CT2-24
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, proteomics, gastric juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric cancer | Experimental | Other: normal subject, Other: gastric cancergastric cancer patients |
| normal subject | Active comparator | Other: normal subject, Other: gastric cancerhealthy subject |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects and gastric cancer patients documented by endoscopy.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal subjectAlso: biomarker in gastric juicebiomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA | Other | gastric cancer, normal subject |
| gastric cancerAlso: biomarker in gastric juicebiomarker in gastric juice, e.g., alpha 1-antitrypsin | Other | gastric cancer, normal subject |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-I Hsu, M.D. principal investigator
Kaohsiung Veterans Genaral hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal subject and gastric cancer in people with Gastric Cancer, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Accurate Diagnosis for Gastric Cancer (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.