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The Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02714335
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Szu-Hua Pan, National Taiwan University

Brief Summary:
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.

Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:
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

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 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
Study Start Date : December 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013



Primary Outcome Measures :
  1. Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP) [ Time Frame: up to 44 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- No

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Responsible Party: Szu-Hua Pan, Dr., National Taiwan University
ClinicalTrials.gov Identifier: NCT02714335    
Other Study ID Numbers: 114764
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Type of publication e.g. poster, abstract, oral presentation etc. Poster and original article
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases