Status:
COMPLETED
Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of the study is to reveal the acquired resistance mechanism of the first and second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in tissue and plasma ...
Detailed Description
With the deepening of the concept of tumor management, it is necessary to monitor the patient's gene during the course of treatment, especially in patients with acquired resistance of the first genera...
Eligibility Criteria
Inclusion
- EGFR mutations were confirmed by molecular pathology.
- Patients who were treated by the first and the second generation EGFR-TKI.
- Patients were evaluated PD according to RECIST imaging standard.
- Patients with functional status score (Performance Status, PS) for 0-2 points according to the Eastern Cooperative Oncology Group (ECOG) .
- Patients can receive histological / cytological specimens through microsurgical biopsy techniques, including but not limited to transbronchial biopsy (TBB), transbronchial lung biopsy (TBLB), transabonchial needle aspiration (TBNA), CT / ultrasound guided thoracic needle aspiration biopsy (CT / ultrasound guided-TTNA), ultrasound-guided superficial lymph node biopsy.
Exclusion
- Patients received blood transfusion within 1 month.
- Patients suffering from autoimmune diseases, including but not limited to systemic lupus erythematosus, class of wet arthritis, Sjogren's syndrome.
- Patients with severe disease is not suitable for medical biopsy.
- Patients refused to participate in clinical trials.
- Researchers consider that the patient is not suitable for participating in this clinical trial.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03309462
Start Date
September 1 2017
End Date
July 31 2019
Last Update
December 9 2019
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030