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
  Purpose

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


Condition
Carcinoma, Non-Small-Cell Lung

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

blood, pleural fluid, and biopsy.


Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00977509     History of Changes
Other Study ID Numbers: 200812092R
Study First Received: September 10, 2009
Last Updated: November 29, 2013
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on April 22, 2014