Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

Advanced Nonsmall Cell Lung Cancer Clinical Trial

Official title:

Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551251
• Other study ID #: 100-0522B
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: July 27, 2015
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug AdministrationTaiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Advanced Nonsmall Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei
Taiwan	Sant Paul Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chen JJ, Lin YC, Yao PL, Yuan A, Chen HY, Shun CT, Tsai MF, Chen CH, Yang PC. Tumor-associated macrophages: the double-edged sword in cancer progression. J Clin Oncol. 2005 Feb 10;23(5):953-64. Epub 2004 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment of advanced NSCLC with high or low TAM.	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.	2-3 months	No
Secondary	Outcomes of advanced NSCLC with high and low TAM.	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.	12-24 months	No