Gene Mutations in Non-Small Cell Lung Cancer Cells

This study is currently recruiting participants.
Verified November 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00977509
First received: September 10, 2009
Last updated: November 29, 2013
Last verified: November 2013

September 10, 2009
November 29, 2013
November 2009
December 2014   (final data collection date for primary outcome measure)
To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy. [ Time Frame: Samples will be collected before the systemic therapy, at the end of the first three months and once every 3 months. In selected consented patients, peripheral blood samples will be collected every week for the first month. ] [ Designated as safety issue: No ]
To determine the frequency of individual genetic abnormality in advanced non-small cell lung cancer (NSCLC) patients who will commence systemic therapy. [ Time Frame: The specimen will be collocted before the systemic therapy. After initiation of therapy, samples will be collected at end of the first month, at the end of the second month, and once every two months thereafter. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00977509 on ClinicalTrials.gov Archive Site
  • To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA sequencing and/or FISH yields a target against which there is approved or investigational therapeutic regimen. [ Time Frame: Samples will be collected before the systemic therapy, at the end of the first three months and once every 3 months. In selected consented patients, peripheral blood samples will be collected every week for the first month. ] [ Designated as safety issue: No ]
  • To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile. [ Time Frame: Disease status will be assessed every 2~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. ] [ Designated as safety issue: Yes ]
  • To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA sequencing and/or FISH yields a target against which there is approved or investigational therapeutic regimen. [ Time Frame: The specimen will be collected before the therapy. After initiation of therapy, samples will be collected at end of the first month, at the end of the second month, and once every two months thereafter. ] [ Designated as safety issue: No ]
  • To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile. [ Time Frame: Disease status will be assessed every 8 weeks and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Gene Mutations in Non-Small Cell Lung Cancer Cells
Detection of Gene Mutations in Non-small Cell Lung Cancer Cells in Blood Samples or Fine-needle Aspiration

To compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

Samples will be collected before the systemic therapy. After initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing CT scans. In selected consented patients, peripheral blood samples will be collected every week for the first month.

Disease status will be assessed every 2~3 months and at the end of treatment according to RECIST criteria. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. Progression-free survival, overall survival and response rate will be reported.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood, pleural fluid, and biopsy.

Non-Probability Sample

primary care clinic

Carcinoma, Non-Small-Cell Lung
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologic or cytological confirmation of NSCLC.
  • Patients must understand and provide written informed consent prior to initiation of any study-specific procedures.
  • Have a life expectancy 3 months.
  • Have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer.
  • Have measurable or evaluable disease.
  • ≥20 years.
  • Candidate for systemic treatment such as EGFR-TKI or chemotherapy.

Exclusion Criteria:

  • Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
Both
20 Years and older
No
Contact: Ya-Ying Bai, M.S. 886-23123456 ext 66589 yaying0508@hotmail.com
Taiwan
 
NCT00977509
200812092R
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Chih-Hsin Yang, M.D., ph.D. National Taiwan University College of Medicine
National Taiwan University Hospital
November 2013

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