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

• Conditions: Nonsmall Cell Lung Cancer; Adenocarcinoma

• Registration Number: NCT02980536
• Lead Sponsor: Berry Genomics Co., Ltd.

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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (9)

Baotou Centry Hospital; 🇨🇳 Baotou, Inner Mongolia, China

Northern Hospital Baotou; 🇨🇳 Baotou, Inner Mongolia, China

The Inner Mongolia Autonomous Region Cancer Hospital; 🇨🇳 Hohhot, Inner Mongolia, China

Baogang Hospital; 🇨🇳 Baotou, Inner Mongolia, China

Bayan Nur Hospital; 🇨🇳 Bayan Nur, Inner Mongolia, China

Dalad Banner People's Hospital; 🇨🇳 Ordos, Inner Mongolia, China

Baotou Cancer Hospital; 🇨🇳 Baotou, Inner Mongolia, China

The Inner Mongolia Autonomous Region People's Hospital; 🇨🇳 Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Inner Monglia Medical University; 🇨🇳 Hohhot, Inner Mongolia, China