Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker
Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers
1 other identifier
observational
353
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 20, 2019
May 1, 2019
1.1 years
July 21, 2016
May 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
AUC(Area Under the Curve)
through study completion, an average of 1 year
Secondary Outcomes (1)
Relative abundance of glycosylations
through study completion, an average of 1 year
Study Arms (2)
Gastric Cancer patients
This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration.
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.
Interventions
In both groups, serum haptoglobins to be collected and analyzed
Eligibility Criteria
Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (7)
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.
PMID: 12671663BACKGROUNDPaik 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.
PMID: 18287765BACKGROUNDAsazawa 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.
PMID: 25060348BACKGROUNDHoagland 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.
PMID: 17918261BACKGROUNDThompson 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.
PMID: 1511415BACKGROUNDPark 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.
PMID: 21780104BACKGROUNDDennis 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.
PMID: 10580127BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2016
First Posted
July 28, 2016
Study Start
July 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2017
Last Updated
May 20, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share