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

NCT ID: NCT02848066

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Measurements of specific glycosylation changes in serum haptoglobin.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric Cancer patients

This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration.

Blood sample(10cc) collection

Intervention Type PROCEDURE

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.

Blood sample(10cc) collection

Intervention Type PROCEDURE

In both groups, serum haptoglobins to be collected and analyzed

Interventions

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Blood sample(10cc) collection

In both groups, serum haptoglobins to be collected and analyzed

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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 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)


* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Etzioni R, Urban N, Ramsey S, McIntosh M, Schwartz S, Reid B, Radich J, Anderson G, Hartwell L. The case for early detection. Nat Rev Cancer. 2003 Apr;3(4):243-52. doi: 10.1038/nrc1041.

Reference Type BACKGROUND
PMID: 12671663 (View on PubMed)

Paik YK, Kim H, Lee EY, Kwon MS, Cho SY. Overview and introduction to clinical proteomics. Methods Mol Biol. 2008;428:1-31. doi: 10.1007/978-1-59745-117-8_1.

Reference Type BACKGROUND
PMID: 18287765 (View on PubMed)

Asazawa H, Kamada Y, Takeda Y, Takamatsu S, Shinzaki S, Kim Y, Nezu R, Kuzushita N, Mita E, Kato M, Miyoshi E. Serum fucosylated haptoglobin in chronic liver diseases as a potential biomarker of hepatocellular carcinoma development. Clin Chem Lab Med. 2015 Jan;53(1):95-102. doi: 10.1515/cclm-2014-0427.

Reference Type BACKGROUND
PMID: 25060348 (View on PubMed)

Hoagland LF 4th, Campa MJ, Gottlin EB, Herndon JE 2nd, Patz EF Jr. Haptoglobin and posttranslational glycan-modified derivatives as serum biomarkers for the diagnosis of nonsmall cell lung cancer. Cancer. 2007 Nov 15;110(10):2260-8. doi: 10.1002/cncr.23049.

Reference Type BACKGROUND
PMID: 17918261 (View on PubMed)

Thompson S, Cantwell BM, Matta KL, Turner GA. Parallel changes in the blood levels of abnormally-fucosylated haptoglobin and alpha 1,3 fucosyltransferase in relationship to tumour burden: more evidence for a disturbance of fucose metabolism in cancer. Cancer Lett. 1992 Aug 14;65(2):115-21. doi: 10.1016/0304-3835(92)90154-n.

Reference Type BACKGROUND
PMID: 1511415 (View on PubMed)

Park SY, Lee SH, Kawasaki N, Itoh S, Kang K, Hee Ryu S, Hashii N, Kim JM, Kim JY, Hoe Kim J. alpha1-3/4 fucosylation at Asn 241 of beta-haptoglobin is a novel marker for colon cancer: a combinatorial approach for development of glycan biomarkers. Int J Cancer. 2012 May 15;130(10):2366-76. doi: 10.1002/ijc.26288. Epub 2011 Sep 22.

Reference Type BACKGROUND
PMID: 21780104 (View on PubMed)

Dennis JW, Granovsky M, Warren CE. Glycoprotein glycosylation and cancer progression. Biochim Biophys Acta. 1999 Dec 6;1473(1):21-34. doi: 10.1016/s0304-4165(99)00167-1.

Reference Type BACKGROUND
PMID: 10580127 (View on PubMed)

Other Identifiers

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2015-07-146

Identifier Type: -

Identifier Source: org_study_id

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