Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02848066
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(Area Under the Curve)', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Relative abundance of glycosylations', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '12671663', 'type': 'BACKGROUND', '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. doi: 10.1038/nrc1041.'}, {'pmid': '18287765', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25060348', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17918261', 'type': 'BACKGROUND', '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. doi: 10.1002/cncr.23049.'}, {'pmid': '1511415', 'type': 'BACKGROUND', '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. doi: 10.1016/0304-3835(92)90154-n.'}, {'pmid': '21780104', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10580127', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Measurements of specific glycosylation changes in serum haptoglobin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Arm1- Gastric cancer patient: 150 subjects Arm2- Cancer-free healthy volunteers : 203', 'healthyVolunteers': True, 'eligibilityCriteria': 'Arm1 (Gastric cancer patient)\n\n1. Inclusion Criteria:\n\n * Male or female over 19 years\n * Patients with histologically Gastric Cancer (included Gastroesphageal junction)\n * Primary gastric cancer or/and metastatic gastric cancer.\n * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted\n2. Exclusion Criteria:\n\n * Prior or present history of malignancies other than gastric cancer\n * Any condition that confounds the ability to interpret data from the study under the investigational confirmed.\n\nArm2 (Cancer-free healthy volunteers)\n\n1. Inclusion Criteria:\n\n * Male or female over 19 years\n * Cancer-free status.\n * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted\n2. Exclusion Criteria:\n\n * Prior or present history of malignancies (included gastric cancer)\n * Any condition that confounds the ability to interpret data from the study under the investigational confirmed'}, 'identificationModule': {'nctId': 'NCT02848066', 'briefTitle': 'Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers', 'orgStudyIdInfo': {'id': '2015-07-146'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Blood sample(10cc) collection', 'type': 'PROCEDURE', 'description': 'In both groups, serum haptoglobins to be collected and analyzed', 'armGroupLabels': ['Cancer-free healthy volunteers', 'Gastric Cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}