Gene Mutations in Non-Small Cell Lung Cancer Cells

National Taiwan University

Status: Unknown

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Other

Identifiers

NCT00977509

200812092R

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.