Gene Mutations in Non-Small Cell Lung Cancer Cells

National Taiwan University Hospital200 enrolled

Overview

To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

Samples will be collected before the systemic therapy. After initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing CT scans. In selected consented patients, peripheral blood samples will be collected every week for the first month. Disease status will be assessed every 2\~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. Progression-free survival, overall survival and response rate will be reported.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologic or cytological confirmation of NSCLC. * Patients must understand and provide written informed consent prior to initiation of any study-specific procedures. * Have a life expectancy 3 months. * Have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer. * Have measurable or evaluable disease. * ≥20 years. * Candidate for systemic treatment such as EGFR-TKI or chemotherapy. Exclusion Criteria: * Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy.

Time frame: Samples will be collected before the systemic therapy, at the end of the first three months and once every 3 months. In selected consented patients, peripheral blood samples will be collected every week for the first month.

Secondary Outcomes

To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA sequencing and/or FISH yields a target against which there is approved or investigational therapeutic regimen.

To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile.

Time frame: Disease status will be assessed every 2~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.

Central Contacts

Ya-Ying Bai, M.S.

CONTACT

886-23123456 yaying0508@hotmail.com

Data from ClinicalTrials.gov

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