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
  Purpose

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.


Condition
Advanced Nonsmall Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 107
Study Start Date: January 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551251

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sant Paul Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Fu-Tsai Chung, M.D. Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Chung Fu-Tsai, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01551251     History of Changes
Other Study ID Numbers: 100-0522B
Study First Received: March 8, 2012
Last Updated: March 9, 2012
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014