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

This study is currently recruiting participants.
Verified December 2016 by Berry Genomics Co., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980536
First Posted: December 2, 2016
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shanghai Chest Hospital
Baotou Cancer Hospital Inner-Mongolia
Information provided by (Responsible Party):
Berry Genomics Co., Ltd.
  Purpose
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.

Condition
Nonsmall Cell Lung Cancer Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Berry Genomics Co., Ltd.:

Primary Outcome Measures:
  • The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient [ Time Frame: 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:
  • The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
There are two types of biospecimen collected in this study. One is the tumor tissue sample taken by biopsy. The other is the plasma sample from the blood.

Estimated Enrollment: 1120
Study Start Date: November 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Stage III and Stage IV NSCLC, adenocarcinoma.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980536


Contacts
Contact: Chun Chun ZhuGE, PhD 1+8618516272857 zhugechunchun711@berrygenomics.com
Contact: Tianyang Wang, PhD +8613331013003

Locations
China, Inner Mongolia
Baogang Hospital Recruiting
Baotou, Inner Mongolia, China, 014010
Contact: Hua Zhang, MS    18947721055    49101707@qq.com   
Baotou Cancer Hospital Recruiting
Baotou, Inner Mongolia, China, 014030
Contact: Zhiying Meng, MD    13847232691    mengzhiyingzhang@sina.com   
Principal Investigator: Xiaohong Wang, MD         
Northern Hospital Baotou Recruiting
Baotou, Inner Mongolia, China, 014030
Contact: Fengyun Wang, MD    15047243095    wfy2826@163.com   
Baotou Centry Hospital Recruiting
Baotou, Inner Mongolia, China, 014040
Contact: Shubing Wang, MD    13634729118    wangtree2000@163.com   
Bayan Nur Hospital Recruiting
Bayan Nur, Inner Mongolia, China, 015000
Contact: Xiaoyu Shi, MD    18847826283    bingyan02551@163.com   
The Inner Mongolia Autonomous Region Cancer Hospital Recruiting
Hohhot, Inner Mongolia, China, 010017
Contact: Xiaoqiong Jia, MD    13947186490    jiaxiaoqiong2005@126.com   
Contact: Zhenping Wen, MD    13848119938    wzp1126@sohu.com   
The Inner Mongolia Autonomous Region People's Hospital Recruiting
Hohhot, Inner Mongolia, China, 010017
Contact: Hui Li, MD    18047192429    lihui2329@163.com   
The First Affiliated Hospital of Inner Monglia Medical University Recruiting
Hohhot, Inner Mongolia, China, 010050
Contact: Xiuhua Fu, MD    13947142625    fuxiuhua555@sohu.com   
Dalad Banner People's Hospital Recruiting
Ordos, Inner Mongolia, China, 104300
Contact: Qiong Qin, MD    13789772388    1095479403@qq.com   
Sponsors and Collaborators
Berry Genomics Co., Ltd.
Shanghai Chest Hospital
Baotou Cancer Hospital Inner-Mongolia
Investigators
Study Chair: Shun Lu, MD/PhD Shanghai Chest Hospital
  More Information

Publications:
Responsible Party: Berry Genomics Co., Ltd.
ClinicalTrials.gov Identifier: NCT02980536     History of Changes
Other Study ID Numbers: BerryGenomics NMB
First Submitted: November 27, 2016
First Posted: December 2, 2016
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Berry Genomics Co., Ltd.:
NSCLC
TKI
Mutation
Liquid Biopsy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases