Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

Completed

• Conditions: Advanced Nonsmall Cell Lung Cancer

• Registration Number: NCT01551251
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-12
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• advanced NSCLC,
• more than 20 years old,
• measurable tumor,
• response and outcome recorded after the first line treatment.

Exclusion Criteria

• Early stage NSCLC,
• less than 20 years,
• pregnancy,
• unmeasurable NSCLC.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment of advanced NSCLC with high or low TAM.	2-3 months	All patients with advanced non-small cell lung cancer (NSCLC) who had been treated were included. The decision of advanced NSCLC treatment was a consensus by the patient and clinician, and approved by team conference (including the oncologists, pulmonologists, pathologists, radiologists, surgeons, radiation oncologists, and nuclear medicine specialists). The tumor response was evaluated using computerized tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST). The treatment response of advanced between high and low TAM patients were compared.

Secondary Outcome Measures

Name	Time	Method
Outcomes of advanced NSCLC with high and low TAM.	12-24 months	The outcomes of advanced NSCLC with high and low TAM will be compared. The outcomes include overall survival (OS) and progression-free survival (PFS). Survival curves were estimated by the Kaplan-Meier method while the log-rank test was used to compare the patient survival times per groups.

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan

Sant Paul Hospital; 🇨🇳 Taoyuan, Taiwan