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

Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02848066
Enrollment
353
Registered
2016-07-28
Start date
2015-07-31
Completion date
2017-09-30
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

PROCEDUREBlood sample(10cc) collection

In both groups, serum haptoglobins to be collected and analyzed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Arm1 (Gastric cancer patient) 1. 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 2.

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.

Design outcomes

Primary

MeasureTime frame
AUC(Area Under the Curve)through study completion, an average of 1 year

Secondary

MeasureTime frame
Relative abundance of glycosylationsthrough study completion, an average of 1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026