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

Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02980536
• Other study ID #: BerryGenomics NMB
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Berry Genomics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Nonsmall Cell Lung Cancer

Locations

Country	Name	City	State
China	Baogang Hospital	Baotou	Inner Mongolia
China	Baotou Cancer Hospital	Baotou	Inner Mongolia
China	Baotou Centry Hospital	Baotou	Inner Mongolia
China	Northern Hospital Baotou	Baotou	Inner Mongolia
China	Bayan Nur Hospital	Bayan Nur	Inner Mongolia
China	The First Affiliated Hospital of Inner Monglia Medical University	Hohhot	Inner Mongolia
China	The Inner Mongolia Autonomous Region Cancer Hospital	Hohhot	Inner Mongolia
China	The Inner Mongolia Autonomous Region People's Hospital	Hohhot	Inner Mongolia
China	Dalad Banner People's Hospital	Ordos	Inner Mongolia

Sponsors (3)

Lead Sponsor	Collaborator
Berry Genomics Co., Ltd.	Baotou Cancer Hospital Inner-Mongolia, Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy		1 year