Non Small Cell Lung Cancer Clinical Trial
Official title:
A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change of CTC Enumeration in Advanced NSCLC With 1st or 2nd Line Line Chemotherapy and Targeted Therapy
TITLE : A Multicenter, Prospective, Observational Trial on the Prognostic and Dynamic Change
of CTC Enumeration in Advanced NSCLC with 1st or 2nd line chemotherapy and targeted therapy
BACKGROUND : Circulating tumor cells (CTC) identification is a new field of research in
oncology, and some studies have been conducted with success on breast and prostate cancer.
Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). CTC
identification and monitoring these cells after treatment could help the clinicians to
detect relapse or be a prognostic factor.
PRIMARY OBJECTIVE : To study the relationship between CTC count and clinical outcome of
treatment (Overall response rate and Progression-free survival).
SECONDARY OBJECTIVES :To study the relationship between CTC and overall survival.
STUDY DESIGN : This is a prospective, observational study.
Duration of the inclusions: 12months.
SAMPLE SIZE : 1200 patients
This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy and targeted-therapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the treatment. Relationship between CTC count and clinical outcome will be analysed. The time points of blood drawing are set as following: for patients receiving chemotherapy, once prior to 1st cycle of chemotherapy, once 3 days prior to 2nd cycle of chemotherapy, posterior to 3th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD); for patients receiving targeted-therapy, once prior to treatment, once 1 month after treatment, and once when PD. The clinical outcome of treatment will be ultimately obtained. ;
Observational Model: Case-Only, Time Perspective: Prospective
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