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Liquid Biopsy for Detection of Driver Mutation in NSCLC

C

Chinese PLA General Hospital (301 Hospital)

Status

Unknown

Conditions

Non Small Cell Lung Cancer

Treatments

Genetic: detection of driver mutation

Study type

Observational

Funder types

Other

Identifiers

NCT02778854
S2015-099-01

Details and patient eligibility

About

The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .

Full description

Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

cohort 1

Inclusion Criteria:

  • patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
  • Age ≥ 18 years
  • newly diagnosed patients have not received TKI and chemotherapy
  • patients who are drug-resistant have not received next-generation TKI

Exclusion Criteria:

  • patients who have more than one type of carcinoma
  • patients who reject to sign the informed consent from

cohort 2

Inclusion Criteria:

  • patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
  • patients will have regular follow-up in Chinese people liberation army general hospital every month.

Exclusion Criteria:

  • patients who are refused to provide the informed consent from

Trial design

200 participants in 2 patient groups

cohort 1
Description:
Participants are recruited for diagnostic test
Treatment:
Genetic: detection of driver mutation
cohort 2
Description:
participants are recruited for follow-up
Treatment:
Genetic: detection of driver mutation

Trial contacts and locations

1

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Central trial contact

Liang-an Chen, MD,PHD

Data sourced from clinicaltrials.gov

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