Liquid Biopsy for Detection of Driver Mutation in NSCLC

NCT ID: NCT02778854

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-11-30

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort 1

Participants are recruited for diagnostic test

detection of driver mutation

Intervention Type GENETIC

participants are received gene detection via the liquid biopsy

cohort 2

participants are recruited for follow-up

detection of driver mutation

Intervention Type GENETIC

participants are received gene detection via the liquid biopsy

Interventions

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detection of driver mutation

participants are received gene detection via the liquid biopsy

Intervention Type GENETIC

Eligibility Criteria

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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


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

cohort 2


* patients who are refused to provide the informed consent from
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Liang_An

MD,PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liang-an Chen, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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department of respiratory department ,Chinese PLA general hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liang-an Chen, MD,PHD

Role: CONTACT

8610-55499027

Facility Contacts

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Liang-an Chen, MD,PHD

Role: primary

8610-55499027

References

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Wu Z, Yang Z, Li CS, Zhao W, Liang ZX, Dai Y, Zhu Q, Miao KL, Cui DH, Chen LA. Differences in the genomic profiles of cell-free DNA between plasma, sputum, urine, and tumor tissue in advanced NSCLC. Cancer Med. 2019 Mar;8(3):910-919. doi: 10.1002/cam4.1935. Epub 2019 Feb 14.

Reference Type DERIVED
PMID: 30767431 (View on PubMed)

Other Identifiers

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S2015-099-01

Identifier Type: -

Identifier Source: org_study_id

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