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Genotyping of Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02002117
Recruitment Status : Unknown
Verified July 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2013
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The logical next step is to integrate molecular profiling into the care of all patients with NSCLC.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Gene Abnormality Other: DNA mass

Detailed Description:
NSCLC is an area of oncology in which clinicians are beginning to use specific tumor-associated molecular aberrations to assign and/or prioritize targeted therapies for patients. At this early stage, multiple hurdles remain before molecular profiling becomes a routine part of thoracic oncology practice. In particular, to develop specific targeted therapies for patients whose tumors harbor rare mutations, it will be important to identify appropriate candidates, design the appropriate trials, and execute the trials with adequate numbers to achieve the necessary endpoints. Implementation will facilitate realization of the promise of molecularly tailored therapy, which could lead to more effective treatments with fewer side effects.

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Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Genotyping of Non-small Cell Lung Cancer Cells - A Study of Taiwan Lung Cancer Clinical Trial Consortium (TALCC)
Study Start Date : January 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
DNA mass spectrometry
DNA mass spectrometry
Other: DNA mass
DNA mass spectrometry




Primary Outcome Measures :
  1. frequency of individual genotyping [ Time Frame: 2 months ]
    To determine the frequency of individual genotyping in cancer cells of advanced non-small cell lung cancer (NSCLC) patients who have participated or will commence the clinical trial.


Secondary Outcome Measures :
  1. determine the frequency by DNA mass spectrometry [ Time Frame: 2 months ]
    To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA mass spectrometry yields a target against which there is approved or investigational therapeutic regimen.

  2. response rate [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
tissue and plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We plan to collect 300 EGFR mutation positive samples (approximately 200 de novo, 100 after treatment), 200 EGFR wild type adenocarcinoma patients and 100 other NSCLC patients in 3 years.
Criteria

Inclusion Criteria:

  1. Patients who have participated or will be participating a lung cancer clinical trial that use EGFR-TKI or chemotherapy as first line or second line treatment.
  2. Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
  3. Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
  4. Have a life expectancy 3 months.
  5. Have stage IV NSCLC (AJCC, 7th Edition)
  6. No or one prior systemic therapy for advanced or metastatic NSCLC 6.1.Adjuvant chemotherapy: The adjuvant chemotherapy (e.g. vinorelbine / cisplatin) should be counted as one prior systemic therapy if the interval between the completion of adjuvant chemotherapy and the documentation of recurrence within 12 months.

    6.2.Maintenance therapy: The maintenance therapy (e.g. pemetrexed) following the first-line systemic chemotherapy which achieved complete response, partial response, or stable disease should not be counted as one prior systemic therapy if the maintenance drug was used in first-line combination therapy

  7. ≥20 years
  8. ECOG performance status 0 - 2
  9. If there is no available archived tissue, the subject must consent to undergo a biopsy or surgical procedure to obtain tissue within 1 month prior to study entry, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

  1. 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.
  2. Known HIV infection.
  3. If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing

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): NCT02002117


Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yaying Bai, MSc    889911572423    yaying0508@ntuh.gov.tw   
Principal Investigator: Chih-Hsin Yang, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chih-Hsin Yang, PhD
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02002117    
Other Study ID Numbers: 201103039RB
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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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