Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT01740804
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2012-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic Circulating Tumor Cell (CTC) Changes During the Chemotherapy in NSCLC
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Study Overview
Official Title:
A Prospective Observational Study on the Dynamic Changes of CTC Enumeration in Advanced NSCLC With 1st Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLICE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: