Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02714335
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP)', 'timeFrame': 'up to 44 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile, it is also interesting to study the expression of Preferentially Expressed Antigen In Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan.', 'detailedDescription': 'Considering the low expression rate of MAGE-A3 in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in NSCLC patients in Taiwan. Meanwhile, it is also interesting to study the expression of PRAME and EGFR mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Site will retrieve tissue samples of around 200 cases of NSCLC patients with informed consent including about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stages of IB, IIA, IIB and IIIA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Tissues samples up to 200 cases of NSCLS patients with informed consent, consisting of about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stage of IB, IIA, IIB and IIIA\n\nExclusion Criteria:\n\n\\- No'}, 'identificationModule': {'nctId': 'NCT02714335', 'briefTitle': 'The Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University'}, 'officialTitle': 'An Observational Study to Determine the Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients in Taiwan', 'orgStudyIdInfo': {'id': '114764'}}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '• Type of publication e.g. poster, abstract, oral presentation etc. Poster and original article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szu-Hua Pan', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Szu-Hua Pan', 'investigatorAffiliation': 'National Taiwan University'}}}}