Clinical trial · Observational
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
NCT02848066CI-TRIAL-00038692completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample(10cc) collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Gastric Cancer patients
- description
- This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration.
- interventionNames
- Procedure: Blood sample(10cc) collection
- label
- Cancer-free healthy volunteers
- description
- This arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration.
- interventionNames
- Procedure: Blood sample(10cc) collection
Primary outcomes (1)
- measure
- AUC(Area Under the Curve)
- timeFrame
- through study completion, an average of 1 year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDEtzioni 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 12671663
- BACKGROUNDPaik 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 18287765
- BACKGROUNDAsazawa 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 25060348
- BACKGROUNDHoagland 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 17918261
- BACKGROUNDThompson 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 1511415
- BACKGROUNDPark 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 21780104
- BACKGROUNDDennis 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.