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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714335
• Other study ID #: 114764
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 21, 2016
• Start date: December 2010
• Est. completion date: November 2013

Study information

• Verified date: March 2016
• Source: National Taiwan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Szu-Hua Pan	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP)		up to 44 months	No