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

May 17, 2019 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measurements of specific glycosylation changes in serum haptoglobin.

Study Type

Observational

Enrollment (Actual)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203

Description

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. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric Cancer patients
This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration.
Procedure: Blood sample(10cc) collection
In both groups, serum haptoglobins to be collected and analyzed
Cancer-free healthy volunteers
This arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration.
Procedure: Blood sample(10cc) collection
In both groups, serum haptoglobins to be collected and analyzed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC(Area Under the Curve)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative abundance of glycosylations
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-07-146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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