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

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ClinicalTrials.gov Identifier: NCT02980536
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
Shanghai Chest Hospital
Baotou Cancer Hospital Inner-Mongolia
Information provided by (Responsible Party):
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.

Condition or disease
Nonsmall Cell Lung Cancer Adenocarcinoma

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 Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
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
Actual Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy




Primary Outcome Measures :
  1. 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 :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
China, Inner Mongolia
Baogang Hospital
Baotou, Inner Mongolia, China, 014010
Baotou Cancer Hospital
Baotou, Inner Mongolia, China, 014030
Northern Hospital Baotou
Baotou, Inner Mongolia, China, 014030
Baotou Centry Hospital
Baotou, Inner Mongolia, China, 014040
Bayan Nur Hospital
Bayan Nur, Inner Mongolia, China, 015000
The Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Inner Mongolia, China, 010017
The Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China, 010017
The First Affiliated Hospital of Inner Monglia Medical University
Hohhot, Inner Mongolia, China, 010050
Dalad Banner People's Hospital
Ordos, Inner Mongolia, China, 104300
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

Publications:
Responsible Party: Berry Genomics Co., Ltd.
ClinicalTrials.gov Identifier: NCT02980536     History of Changes
Other Study ID Numbers: BerryGenomics NMB
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
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