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Acquired Resistant Mechanism of the First-generation EGFR TKIs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804217
Recruitment Status : Unknown
Verified June 2016 by Yu Xinmin, Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Yu Xinmin, Zhejiang Cancer Hospital

Brief Summary:
Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Aquired Resistance EGFR TKIs Other: Genetic: mutation profile

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genomic Mutation Profile Using Next Generation Sequencing for Non-small-cell Lung Cancer Patients With Activating EGFR Mutations Harboring Acquired Resistance to the First-generation EGFR TKIs.
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Genetic: mutation profile
    Other Names:
    • Procedure: Lung tumor biopsy
    • Procedure: Blood sample


Primary Outcome Measures :
  1. mutation profile [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with NSCLC harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
Criteria

Inclusion Criteria:

  • Histologically proven stage IIIB or IV non-small cell lung cancer
  • patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
  • patients who can provide pre-treatment (EGFR TKIs) tumor tissues
  • patients with tumor lesions to be re-biopsy after drug resistance
  • patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

  • History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  • patients with other systemic diseases

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): NCT02804217


Contacts
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Contact: Ying Jin, MD 86-571-88122082 jinying_1987@sina.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xinmin Yu, MD    86-571-88122082    yu_xinm@sina.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
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Responsible Party: Yu Xinmin, Director, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT02804217    
Other Study ID Numbers: IRB-2016-74
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
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