cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patient... | NCT02980536

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

NCT02980536

Sponsor

Berry Genomics Co., Ltd.

Status

Unknown status

Last Update Posted

Jul 11, 2018Actual

Enrollment

129Actual

Phase

Not provided

Conditions

Nonsmall Cell Lung Cancer
Adenocarcinoma

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 27, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2018

Last Update Posted Date

Jul 11, 2018Actual

Name	Class
Shanghai Chest Hospital	OTHER
Baotou Cancer Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

129Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Stage III and Stage IV NSCLC, adenocarcinoma.

Sampling Method

Probability Sample

Name	Affiliation	Role
Shun Lu, MD/PhD	Shanghai Chest Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Baogang Hospital		Baotou	Inner Mongolia	014010	China
Baotou Cancer Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27870944	Background	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.
27071701

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D000230	Adenocarcinoma

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms