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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gastric cancer | Experimental | gastric cancer patients |
|
| normal subject | Active Comparator | healthy subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal subject | Other | biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping-I Hsu, M.D. | Kaohsiung Veterans Genaral hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Kaohsiung | 813 | Taiwan | ||
| Kaohsiung Veterans General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Cancer | gastric cancer patients normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin |
| FG001 | Normal Subject | healthy subject normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Cancer | gastric cancer patients normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin |
| BG001 | Normal Subject |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gastric Cancer | gastric cancer patients normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin |
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The trial was performed in a single country
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ping-I Hsu | Kaohsiung Veterans General Hospital | +886-7-3422121 | 8233 | pihsu@vghks.gov.tw |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
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| gastric cancer | Other | biomarker in gastric juice, e.g., alpha 1-antitrypsin |
|
|
| Kaohsiung City |
| 813 |
| Taiwan |
healthy subject
normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Normal Subject | healthy subject normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin | 0 | 47 | 0 | 47 |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |