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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848066
• Other study ID #: 2015-07-146
• Status: Completed
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: May 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Measurements of specific glycosylation changes in serum haptoglobin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: September 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Blood sample(10cc) collection
In both groups, serum haptoglobins to be collected and analyzed

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

Dennis JW, Granovsky M, Warren CE. Glycoprotein glycosylation and cancer progression. Biochim Biophys Acta. 1999 Dec 6;1473(1):21-34. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Paik YK, Kim H, Lee EY, Kwon MS, Cho SY. Overview and introduction to clinical proteomics. Methods Mol Biol. 2008;428:1-31. Review. — View Citation

Park SY, Lee SH, Kawasaki N, Itoh S, Kang K, Hee Ryu S, Hashii N, Kim JM, Kim JY, Hoe Kim J. a1-3/4 fucosylation at Asn 241 of ß-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(Area Under the Curve)		through study completion, an average of 1 year
Secondary	Relative abundance of glycosylations		through study completion, an average of 1 year