Gastric Cancer
Conditions
Keywords
gastric cancer, proteomics, gastric juice
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.
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.
Interventions
OTHERnormal subject
biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA
OTHERgastric cancer
biomarker in gastric juice, e.g., alpha 1-antitrypsin
Sponsors
National Science and Technology Council, Taiwan
Kaohsiung Veterans General Hospital.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Accurate Diagnosis for Gastric Cancer | 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 |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 47 |
| Total | 76 |
Baseline characteristics
| Characteristic | Normal Subject | Gastric Cancer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 19 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 10 Participants | 52 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 14.9 | 67.5 years STANDARD_DEVIATION 14.3 | 59.5 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment Taiwan | 47 participants | 29 participants | 76 participants |
| Sex: Female, Male Female | 24 Participants | 9 Participants | 33 Participants |
| Sex: Female, Male Male | 23 Participants | 20 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 47 |
| serious Total, serious adverse events | 0 / 29 | 0 / 47 |
Outcome results
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
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gastric Cancer | Number of Participants With Accurate Diagnosis for Gastric Cancer | 27 participants |
| Normal Subject | Number of Participants With Accurate Diagnosis for Gastric Cancer | 44 participants |