Trial Outcomes & Findings for Blood Tests for Gastritis and Gastric Neoplasms (NCT NCT05883345)

NCT ID: NCT05883345

Last Updated: 2025-03-11

Results Overview

Serum pepsinogen I/II ratios indicating the presence gastric neoplasms (Minimum and maximum ratios were 0.2 and 19.1, respectively. Lower ratios indicate worse outcome.)

• Recruitment status: COMPLETED
• Target enrollment: 1490 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2025-03-11

Participant Flow

Participant milestones

Measure	No Gastric Neoplasm Group Individuals without gastric neoplasms	Gastric Neoplasm Group Individuals with gastric neoplasms
Overall Study STARTED	1346	144
Overall Study COMPLETED	979	122
Overall Study NOT COMPLETED	367	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Tests for Gastritis and Gastric Neoplasms

Baseline characteristics by cohort

Measure	No Gastric Neoplasm n=979 Participants Individuals without gastric neoplasms	Gastric Neoplasm n=122 Participants Individuals with gastric neoplasms	Total n=1101 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 15.5 • n=5 Participants	66.8 years STANDARD_DEVIATION 10.1 • n=7 Participants	53.0 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	451 Participants n=5 Participants	42 Participants n=7 Participants	493 Participants n=5 Participants
Sex: Female, Male Male	528 Participants n=5 Participants	80 Participants n=7 Participants	608 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	979 Participants n=5 Participants	122 Participants n=7 Participants	1101 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Status of H. pylori infection Current	355 Number of individuals n=5 Participants	88 Number of individuals n=7 Participants	443 Number of individuals n=5 Participants
Status of H. pylori infection Past	303 Number of individuals n=5 Participants	32 Number of individuals n=7 Participants	334 Number of individuals n=5 Participants
Status of H. pylori infection Naive	321 Number of individuals n=5 Participants	2 Number of individuals n=7 Participants	323 Number of individuals n=5 Participants

PRIMARY outcome

Timeframe: 15 months

Serum pepsinogen I/II ratios indicating the presence gastric neoplasms (Minimum and maximum ratios were 0.2 and 19.1, respectively. Lower ratios indicate worse outcome.)

Outcome measures

Measure	No Gastric Neoplasm n=979 Participants Without gastric neoplasms (n=979)	Gastric Neoplasm n=122 Participants With gastric neoplasms (n=122)
Significant Blood Test Findings Correlated With Gastric Neoplasms	9.9 score on a scale Standard Deviation 3.9	6.5 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 15 months

Gastrin-17 levels measured by the GastroPanel tests on the day of other serologic tests including pepsinogen levels and Helicobacter pylori IgG titers

Outcome measures

Measure	No Gastric Neoplasm n=979 Participants Without gastric neoplasms (n=979)	Gastric Neoplasm n=122 Participants With gastric neoplasms (n=122)
Test Findings Correlated With the Presence of Gastric Neoplasms	2.9 pmol/L Interval 0.4 to 30.0	11.8 pmol/L Interval 0.4 to 30.0

Adverse Events

No Gastric Neoplasm Group

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Gastric Neoplasm Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Gastric Neoplasm Group n=979 participants at risk Individuals without gastric neoplasms	Gastric Neoplasm Group n=122 participants at risk Individuals with gastric neoplasms
Gastrointestinal disorders Perforation, bleeding, infection, etc.	0.00% 0/979 • Adverse events were recorded on the day of examination and on the day of follow-up visit at the outpatient clinic. Time Frame 1: On the day of upper gastrointestinal endoscopy and blood tests Time Frame 2: Up to 6 months Adverse events were defined as symptoms that disturbed daily activities by requiring management to subside the symptoms. Adverse events include perforation, bleeding, infection, cardiopulmonary events, etc.	0.00% 0/122 • Adverse events were recorded on the day of examination and on the day of follow-up visit at the outpatient clinic. Time Frame 1: On the day of upper gastrointestinal endoscopy and blood tests Time Frame 2: Up to 6 months Adverse events were defined as symptoms that disturbed daily activities by requiring management to subside the symptoms. Adverse events include perforation, bleeding, infection, cardiopulmonary events, etc.

Other adverse events

Measure	No Gastric Neoplasm Group n=979 participants at risk Individuals without gastric neoplasms	Gastric Neoplasm Group n=122 participants at risk Individuals with gastric neoplasms
Injury, poisoning and procedural complications Hypoxemia	2.1% 21/979 • Number of events 21 • Adverse events were recorded on the day of examination and on the day of follow-up visit at the outpatient clinic. Time Frame 1: On the day of upper gastrointestinal endoscopy and blood tests Time Frame 2: Up to 6 months Adverse events were defined as symptoms that disturbed daily activities by requiring management to subside the symptoms. Adverse events include perforation, bleeding, infection, cardiopulmonary events, etc.	3.3% 4/122 • Number of events 4 • Adverse events were recorded on the day of examination and on the day of follow-up visit at the outpatient clinic. Time Frame 1: On the day of upper gastrointestinal endoscopy and blood tests Time Frame 2: Up to 6 months Adverse events were defined as symptoms that disturbed daily activities by requiring management to subside the symptoms. Adverse events include perforation, bleeding, infection, cardiopulmonary events, etc.

Additional Information

Sun-Young Lee

Konkuk University Medical Center

Phone: 82-2-2030-7747

Email: sunyoung1973.lee@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place