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Completed

NCT Number: NCT01551251

Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

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.

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Key information

Conditions

Advanced Nonsmall Cell Lung Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Response to treatment of advanced NSCLC with high or low TAM.

    Time frame: 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 outcomes

  1. Outcomes of advanced NSCLC with high and low TAM.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Mar 12, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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