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OpenTrials
Completed

NCT Number: NCT02848066

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

Measurements of specific glycosylation changes in serum haptoglobin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Arm1 (Gastric cancer patient)

  • 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
  • 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)

  • 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
  • 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

Treatment and study plan

Blood sample(10cc) collection

Procedure

In both groups, serum haptoglobins to be collected and analyzed

Primary outcomes

  1. AUC(Area Under the Curve)

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Relative abundance of glycosylations

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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