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

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ClinicalTrials.gov Identifier: NCT02848066
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastric Cancer Procedure: Blood sample(10cc) collection

Detailed Description:
Measurements of specific glycosylation changes in serum haptoglobin.

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Study Type : Observational
Actual Enrollment : 353 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official 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
Actual Study Start Date : July 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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




Primary Outcome Measures :
  1. AUC(Area Under the Curve) [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Relative abundance of glycosylations [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203
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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848066


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

Publications:

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02848066     History of Changes
Other Study ID Numbers: 2015-07-146
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases