Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric Neoplasms
Conditions: Cancer Screening Tests
Sponsor: Konkuk University Medical Center

 
Validation of Serum Assays for the Diagnosis of Gastritis 
 
ClinicalTrials.gov ID: NCT05883345 
Document date: May 28, 2023 
 
 
 
 

Main investigator 
 Name: Sun-Young Lee, MD, PhD  
Address: 120-1 Neungdong-ro, Gwangjin-gu, Seoul 05030, Korea 
 Phone/fax: 82-2-2030-7747/82-2-2030-7748 
 E-mail: sunyoung1973.lee@gmail.com 
 
Number of involved center: 1 (Konkuk University Medical Center) 
Title of the study: Validation of Blood Test Finding for the Diagnosis of Gastritis and Gastric 
Neoplasms 
Protocol ID: 2023-04-056 
Keywords: Helicobacter pylori, Atrophic gastritis, Gastric cancer, Pepsinogen  
 
Rationale of the study 
Helicobacter pylori-seropositive rates are decreasing in South Korea. Seroprevalence was 
74.3% in 1990, but it decreased to 43.9% in 2016. In Koreans, most gastric cancers are 
related to H. pylori infection. H. pylori-negative gastric cancers were found only in 2.3% 
among the 1,833 Korean gastric cancer patients. Despite these facts, the national guideline 
still recommends biennial gastroscopy for all Koreans aged between 40 and 75 years. 
Therefore, 8,462,570 (63.1%) Koreans underwent gastric cancer screening among the target 
population of 13,404,927 individuals in 2021. 
In H. pylori-seroprevalent populations, diagnostic criteria for naive status should be strict 
based on histology, endoscopy, and serum pepsinogen (PG) assay findings. Naive condition 
should be diagnosed only when both invasive and non-invasive H. pylori tests show negative 

findings. Furthermore, there should be no intestinal metaplasia and atrophy on serum PG 
assay, endoscopy, and histology findings in H. pylori-naive participants. Based on those 
findings, H. pylori infection will be confirmed when invasive tests or urea breath test was 
positive. H. pylori-naive status will be diagnosed if there was no eradication history, no 
serologically detected atrophy (PG I ≤70 ng/mL and PG I/II ≤3), and no intestinal metaplasia 
or atrophy on endoscopy and histology. 
This study aimed to determine the validity of blood tests for gastric cancer screening 
according to the H. pylori infection status. We tried to identify significant variables using 
GastroPanel tests and traditional serum PG assays according to the presence gastric 
neoplasms. 
 
Study design 
Study Type 
Observational 
Observational Study Model Cohort 
Time Perspective 
Prospective 
Biospecimen Retention 
Samples Without DNA
Biospecimen Description 
Blood sample 
Enrollment 
1490 [Actual] 
 
Primary objective: To determine the validity of blood tests for gastric cancer screening  
Endpoints:  

• 
Primary endpoint: Significant blood test findings (H. pylori IgG, PGI, PG II, I/II 
ratio, G-17) indicating the presence gastric neoplasms  
• 
Secondary endpoint: Test findings according to the types of gastric neoplasms 
Expected results: GastroPanel test and conventional serum pepsinogen findings would 
differ according to the presence and types of gastric neoplasms. 
Analyzed criteria: Gastric neoplasms were diagnosed when microscopic findings correspond 
to the international classification of diseases-10 categories C16, D002, D131, and C1884. 
Adenocarcinomas (C16 and D002) were further divided into advanced gastric cancers (AGCs) 
and early gastric cancers (EGCs) after resecting the cancers. Gastric adenomas were 
confirmed among benign neoplasms of the stomach (D131), after the resection. Following 
excision of submucosal tumors, neuroendocrine tumors (NETs) and gastrointestinal stromal 
tumors (GISTs) were verified as C16. Primary gastric mucosa-associated lymphoid tissue 
(MALT) lymphomas were identified as C1884 using the gastric biopsy specimens. 
 
Main variables/endpoints of the analysis 
Age (years) 
Male sex 
Status of H. pylori infection 
GastroPanel test findings 
H. pylori IgG (EIU) 
PG I (µg/L) 
PG II (µg/L) 
I/II ratio 
Gastrin-17 (pmol/L) 
Conventional serum assays (Chorus tests and HBI PG assays) 
H. pylori IgG (AU/mL) 
PG I (mg/dL) 
PG II (mg/dL) 
I/II ratio 

 
Safety variables: No adverse events during the study period (May 1, 2023 ~ August 30, 
2024) 
 
Visits and examinations 
Initial visit: 
• 
Blood test for H. pylori immunoglobulin G, pepsinogen, and gastrin-17 levels 
• 
Upper gastrointestinal endoscopy and gastric biopsy 
Follow-up visit: 
• 
13C-urea breath test if there is a discrepancy between the H. pylori test findings 
 
Study population 
 Short description of the main inclusion and exclusion criteria 
Study Population: 
Adult population who visited our center for gastric 
cancer screening using serum assays 
Sampling Method: 
Non-Probability Sample   
Minimum Age: 
18 Years   
Maximum Age: 
99 Years   
Sex: 
All   
Gender Based: 
No   
Accepts Healthy Volunteers: No   

Criteria: 
Inclusion Criteria: 
 
Individuals who visited for gastric cancer 
screening 
Exclusion Criteria: 
 
History of gastrectomy 
 
Renal insufficiency 
 
Severe comorbidities requiring prompt 
management 
 
Sample size and statistical analysis 
Prior to the study, sample size calculation was done for the validation of GastroPanel test 
in Koreans. Briefly, two–sided tests were used at a significance level of 0.05. Using PASS 2023 
(NCSS, LLC. Kaysville, Utah, USA), the power was 0.842 when 414 individuals are included. 
Chi-square test was used for categorical variables, while t-test was used for continuous 
variables to compare the differences between the patients with gastric neoplasms and the 
controls. When the data showed asymmetrical distribution, Fisher’s-exact was used to 
present categorical variables as proportion, while Kruskal-Wallis test was used to present 
continuous variables as median value with ranges. ANOVA with Bonferroni correction was 
used to assess differences between the three groups for continuous variables, while chi-
square test with Bonferroni correction was used for categorical variables. Thereafter, 
independent variables for gastric neoplasms were identified using logistic regression analysis. 
The results are shown as odds ratio (OR) with 95% confidence intervals (CIs). Correlation 
analysis was used to identify associations between the blood test results and the severity of 

atrophy. The results are shown as correlation coefficient (r) values. Furthermore, receiver 
operating characteristic (ROC) curve analysis was done, and presented as area under the curve 
(AUC). ROC curves were compared using the McNemar's test. Using PASW statistics (version 
28.0; SPSS Inc., Chicago, IL, USA), a p-value less than 0.05 was considered significant. 
 
Duration of the study 
Study Start: 
May 1, 2023   [Actual]
Primary Completion: August 30, 2024   
 
Additional features on the main concept of the study 
Serum pepsinogen (PG) assays are another method used to quantify the severity of atrophy, 
in addition to endoscopic and microscopic measurements. In contrast to traditional serum PG 
assays, GastroPanel tests incorporate the measurement of gastrin-17 (G-17), a substance 
exclusively secreted by the gastric antrum. The G-17 level decreases to less than 1 pmol/L 
following distal gastrectomy or in the presence of antral atrophy, but it increases to 30 pmol/L 
when corpus atrophy develops. European studies using GastroPanel tests revealed that 
gastric atrophy can be identified with low G-17 levels of <1 pmol/L. Nonetheless, this metric 
is difficult to apply in H. pylori-seroprevalent areas where corpus atrophy is common. A 
Chinese study showed that gastric cancer development is linked to both low (<0.5 pmol/L) 
and high (>4.7 pmol/L) G-17 levels; however, these are less helpful in clinical practice because 
G-17 levels of >4.7 pmol/L are frequently observed even in the absence of atrophy. Altogether, 
it is still uncertain whether adding a G-17 measurement to PG assays would contribute to the 
detection of gastric neoplasms. Hence, we attempted to identify actual blood levels for 

detecting gastric neoplasms rather than focusing on identifying high-risk individuals. 
Additionally, we tried to confirm the significance of the test results according to the type of 
gastric neoplasm.