Clinical trial NCT02980536: cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonsmall Cell Lung Cancer
Adenocarcinoma
Keywords: NSCLC
TKI
Mutation
Liquid Biopsy
Lead sponsor: Berry Genomics Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Chest Hospital
name: Baotou Cancer Hospital
First posted: 2016-12-02
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Stage III and Stage IV NSCLC, adenocarcinoma.

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

Eligibility criteria: 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

Primary outcomes:
measure: The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
timeFrame: 1.5 years
Secondary outcomes:
measure: The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy
timeFrame: 1 year
Other outcomes:
Locations:
city: Baotou
country: China
facility: Baogang Hospital
state: Inner Mongolia
city: Baotou
country: China
facility: Baotou Cancer Hospital
state: Inner Mongolia
city: Baotou
country: China
facility: Northern Hospital Baotou
state: Inner Mongolia
city: Baotou
country: China
facility: Baotou Centry Hospital
state: Inner Mongolia
city: Bayan Nur
country: China
facility: Bayan Nur Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Inner Mongolia Autonomous Region Cancer Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The First Affiliated Hospital of Inner Monglia Medical University
state: Inner Mongolia
city: Ordos
country: China
facility: Dalad Banner People's Hospital
state: Inner Mongolia
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, MD/PhD
role: STUDY_CHAIR
References:
citation: Wang Z, Cheng G, Han X, Mu X, Zhang Y, Cui D, Liu C, Zhang L, Fan Z, Ma L, Yang L, Di J, Cram DS, Shi Y, Liu D. Application of Single-Molecule Amplification and Resequencing Technology for Broad Surveillance of Plasma Mutations in Patients with Advanced Lung Adenocarcinoma. J Mol Diagn. 2017 Jan;19(1):169-181. doi: 10.1016/j.jmoldx.2016.09.008. Epub 2016 Nov 19.
citation: Chai X, Ren P, Wei B, Ma J, Mai L, Cram DS, Song Y, Guo Y. A comparative study of EGFR oncogenic mutations in matching tissue and plasma samples from patients with advanced non-small cell lung carcinoma. Clin Chim Acta. 2016 Jun 1;457:106-11. doi: 10.1016/j.cca.2016.04.003. Epub 2016 Apr 9.
citation: Song Y, Zhou X, Huang S, Li X, Qi Q, Jiang Y, Liu Y, Ma C, Li Z, Xu M, Cram DS, Liu J. Quantitation of fetal DNA fraction in maternal plasma using circulating single molecule amplification and re-sequencing technology (cSMART). Clin Chim Acta. 2016 May 1;456:151-156. doi: 10.1016/j.cca.2016.03.005. Epub 2016 Mar 15.
citation: Lv W, Wei X, Guo R, Liu Q, Zheng Y, Chang J, Bai T, Li H, Zhang J, Song Z, Cram DS, Liang D, Wu L. Noninvasive prenatal testing for Wilson disease by use of circulating single-molecule amplification and resequencing technology (cSMART). Clin Chem. 2015 Jan;61(1):172-81. doi: 10.1373/clinchem.2014.229328. Epub 2014 Nov 6.