cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China

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

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to evaluate the mutation pattern of epidermal growth factor receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient with liquid biopsy.

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Detailed Description

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In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. the study will be ended when all the patients had a progressive disease (PD) in their targeted lesion

Conditions

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Nonsmall Cell Lung Cancer Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* NSCLC adenocarcinoma patients confirmed by pathologist
* Initial, non-operative patients with stage III \& IV adenocarcinoma
* Older than 18 years old
* Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN ( Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.

PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;

* Have a clear measurable tumor lesion in lung,under RIEST.
* Without severe drug allergy
* Patients participate in this trail must sign the informed consent

Exclusion Criteria

* Patients with brain metases related syndrome
* Patients with bone metases related complication
* Patients with cognitive disorder
* Patients with major organ dysfunction and severe cardiopathy include congestive heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).
* Patients with other severe complication and excluded by the researcher.
* Patients who are allergy with the TKI in this trail.
* Patients who participated in other trails or with anti-tumor treatments
* Patients who receive radiotherapy at the site of curative effect observation
* Patients who receive allogenic blood transfusion within 14 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No