NCT01740804

Dynamic Circulating Tumor Cell (CTC) Changes During the Chemotherapy in NSCLC

A Prospective Observational Study on the Dynamic Changes of CTC Enumeration in Advanced NSCLC With 1st Line Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary endpoint To observe the dynamic changes of CTC during the process of platinum based chemotherapy in advanced NSCLC. To study the relationship between CTC count and clinical outcome of chemotherapy (ORR and PFS). Secondary endpoint To study the relationship between CTC and overall survival. To study the molecular feature of CTC, such as epidermal growth factor receptor (EGFR), KRAS, CD117, etc.

Detailed description

This is a prospective observational non-intervention study evaluating the dynamic CTC count during the chemotherapy. Patients provide written informed consent and pass the screening. Peripheral blood will be drawn before and after the first line chemotherapy. Analyze the relationship between CTC count and clinical outcome. The time points of blood drawing are set as following: once prior to 1st cycle of chemotherapy, once 1 week prior to 2nd cycle of chemotherapy, posterior to 4th cycle (or less than 4th cycle) of chemotherapy and once when progressive disease (PD). The specific blood tube CellSave Tube will be used, 7.5ml blood sample every time. One follow-up (including by phone) be made every 3 month after PD until death. The clinical outcome of first line chemotherapy will be ultimately obtained.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Cell, Circulating Tumor

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2012-12-04
• Last updated: 2016-12-05

Locations

1 site across 1 country: China