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

The Oncogenic Mutation Detection of Advanced NSCLC Patients by cSMART Liquid Biopsy and Dynamic Monitor of Tyrosine Kinase Inhibitor(TKI) Efficiency in Inner-Mongolia China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02980536

Enrollment

129

Registered

2016-12-02

Start date

2016-11-30

Completion date

2018-12-31

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Nonsmall Cell Lung Cancer

Keywords

NSCLC, TKI, Mutation, Liquid Biopsy

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient	1.5 years	The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.

Secondary

Measure	Time frame
The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy	1 year

Countries

China

Outcome results