Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chung Fu-Tsai, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01551251
First received: March 8, 2012
Last updated: March 9, 2012
Last verified: April 2011

March 8, 2012
March 9, 2012
January 2006
December 2010   (final data collection date for primary outcome measure)
Response to treatment of advanced NSCLC with high or low TAM. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01551251 on ClinicalTrials.gov Archive Site
Outcomes of advanced NSCLC with high and low TAM. [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer
Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

All specimens were fixed in 10% buffered formalin and embedded in paraffin according to standard procedures. All of the tissues were fixed immediately after biopsy, with time from tissue acquisition to fixation as short as possible. Serial sections (4 μm thickness) placed on positively charged slides (Menzel-Glasser, German) were used for immuno-histochemistry.

Non-Probability Sample

All patients with advanced non-small cell lung cancer (stage IIIb and IV NSCLC) who had been treated at the Linkou Branch of Chang Gung Memorial Hospital between 2006 and 2009 were included.

Advanced Nonsmall Cell Lung Cancer
Not Provided
  • Advanced NSCLC with high TAM
    All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with high TAM were included as one cohort group.
  • Advanced NSCLC with low TAM
    All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with low TAM were included as one cohort group.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01551251
100-0522B
Yes
Chung Fu-Tsai, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Fu-Tsai Chung, M.D. Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP