Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Blood sample(10cc) collection

• Registration Number: NCT02848066
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers.

Detailed Description

Measurements of specific glycosylation changes in serum haptoglobin.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

• Male or female over 19 years
  • Patients with histologically Gastric Cancer (included Gastroesphageal junction)
  • Primary gastric cancer or/and metastatic gastric cancer.
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted

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Exclusion Criteria

• Prior or present history of malignancies other than gastric cancer
  • Any condition that confounds the ability to interpret data from the study under the investigational confirmed.

Arm2 (Cancer-free healthy volunteers)

1. Inclusion Criteria:

   • Male or female over 19 years
   • Cancer-free status.
   • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted

2. Exclusion Criteria:

   • Prior or present history of malignancies (included gastric cancer)
   • Any condition that confounds the ability to interpret data from the study under the investigational confirmed

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer-free healthy volunteers	Blood sample(10cc) collection	This arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration.
Gastric Cancer patients	Blood sample(10cc) collection	This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration.

Primary Outcome Measures

Name	Time	Method
AUC(Area Under the Curve)	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Relative abundance of glycosylations	through study completion, an average of 1 year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of