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Gene Mutations in Non-Small Cell Lung Cancer Cells

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ClinicalTrials.gov Identifier: NCT00977509
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2009
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Gene Mutations in Non-small Cell Lung Cancer Cells in Blood Samples or Fine-needle Aspiration
Study Start Date : November 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

Biospecimen Retention:   Samples With DNA
blood, pleural fluid, and biopsy.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977509


Contacts
Contact: Ya-Ying Bai, M.S. 886-23123456 ext 66589 yaying0508@hotmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chih-Hsin Yang, M.D., Ph.D.    886-2-23123456 ext 67511    chihyang@ntu.edu.tw   
Principal Investigator: Chih-Hsin Yang, M.D., Ph.D.         
Sub-Investigator: Jih-Hsiang Lee, M.D.         
Sub-Investigator: Chong-Jen Yu, M.D., Ph.D.         
Sub-Investigator: Jin-Yuan Shih, M.D., Ph.D.         
Sub-Investigator: Chao-Chi Ho, M.D., Ph.D.         
Sub-Investigator: Wei-Yu Liao, M.D.         
Sub-Investigator: Kuan-Yu Chen, M.D., Ph.D.         
Sub-Investigator: Chia-Chi Lin, M.D., Ph.D.         
Sub-Investigator: Yu-Lin Lin, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chih-Hsin Yang, M.D., ph.D. National Taiwan University College of Medicine

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00977509     History of Changes
Other Study ID Numbers: 200812092R
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

Keywords provided by National Taiwan University Hospital:
genes
mutation
non-small cell lung cancer
cancer cells

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