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

NCT02980536 | Unknown DMC

• 1 other identifier: BerryGenomics NMB
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 9

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.

Conditions

Nonsmall Cell Lung Cancer; Adenocarcinoma

Keywords

NSCLC; TKI; Mutation; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient

  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.

  1.5 years

Secondary Outcomes (1)

• The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Stage III and Stage IV NSCLC, adenocarcinoma.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Berry Genomics Co., Ltd.: lead
• Shanghai Chest Hospital: collaborator
• Baotou Cancer Hospital: collaborator

Study Sites (9)

Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

Baotou Cancer Hospital

Baotou, Inner Mongolia, 014030, China

Location

Northern Hospital Baotou

Baotou, Inner Mongolia, 014030, China

Location

Baotou Centry Hospital

Baotou, Inner Mongolia, 014040, China

Location

Bayan Nur Hospital

Bayan Nur, Inner Mongolia, 015000, China

Location

The Inner Mongolia Autonomous Region Cancer Hospital

Hohhot, Inner Mongolia, 010017, China

Location

The Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, 010017, China

Location

The First Affiliated Hospital of Inner Monglia Medical University

Hohhot, Inner Mongolia, 010050, China

Location

Dalad Banner People's Hospital

Ordos, Inner Mongolia, 104300, China

Location

Related Publications (4)

• 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.

  PMID: 27870944 BACKGROUND

• 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.

  PMID: 27071701 BACKGROUND

• 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.

  PMID: 26993877 BACKGROUND

• 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.

  PMID: 25376582 BACKGROUND

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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Shun Lu, MD/PhD

  Shanghai Chest Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)