Gene Mutations in Non-Small Cell Lung Cancer Cells
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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 |
- 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 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: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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 |
primary care clinic
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| Contact: Ya-Ying Bai, M.S. | 886-23123456 ext 66589 | yaying0508@hotmail.com |
| 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. | |
| 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: | December 6, 2012 |
| 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 May 19, 2013