Trial Outcomes & Findings for Proteiomic Fingerprints of Gastric Juice (NCT NCT00834236)

Last Updated: 2015-12-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

2 months

Results posted on

2015-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	29	47
Overall Study COMPLETED	29	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proteiomic Fingerprints of Gastric Juice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastric Cancer n=29 Participants 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	Normal Subject n=47 Participants 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	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	42 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 14.3 • n=5 Participants	51.4 years STANDARD_DEVIATION 14.9 • n=7 Participants	59.5 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	24 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment Taiwan	29 participants n=5 Participants	47 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Gastric Cancer n=29 Participants 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	Normal Subject n=47 Participants 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
Number of Participants With Accurate Diagnosis for Gastric Cancer	27 participants	44 participants

Adverse Events

Gastric Cancer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Subject

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place