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Liquid Biopsy for Detection of Driver Mutation in NSCLC

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ClinicalTrials.gov Identifier: NCT02778854
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Chen Liang_An, Chinese PLA General Hospital

Brief Summary:
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 .

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Genetic: detection of driver mutation

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
cohort 1
Participants are recruited for diagnostic test
Genetic: detection of driver mutation
participants are received gene detection via the liquid biopsy

cohort 2
participants are recruited for follow-up
Genetic: detection of driver mutation
participants are received gene detection via the liquid biopsy




Primary Outcome Measures :
  1. concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC [ Time Frame: 6 months ]
  2. changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis [ Time Frame: 5 years ]
  3. Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy [ Time Frame: 3 years ]
    compare the PFS between each participants via the change of driver mutation

  4. Overall survival(OS) in patients who had driver mutation and received the molecular target therapy [ Time Frame: 5 years ]
    compare the OS between each participants via the change of driver mutation


Biospecimen Retention:   Samples With DNA
body fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who have been diagnosed with NSCLC and received detection of driver mutation in Chinese PLA general hospital
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

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): NCT02778854


Contacts
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Contact: Liang-an Chen, MD,PHD 8610-55499027 cla301@126.com

Locations
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China, Beijing
department of respiratory department ,Chinese PLA general hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Liang-an Chen, MD,PHD    8610-55499027    cla301@126.com   
Principal Investigator: Liang-an Chen, MD,PHD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Liang-an Chen, MD,PHD Chinese PLA General Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chen Liang_An, MD,PHD, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02778854     History of Changes
Other Study ID Numbers: S2015-099-01
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: considering of personal privacy, the research-related individual participant data do not intend for public sharing.

Keywords provided by Chen Liang_An, Chinese PLA General Hospital:
NSCLC
liquid biopsy
driver mutation

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases