Dynamic Changes of Circulating Tumor DNA in Late Stage NS... | NCT02804100

Studies
Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

NCT02804100

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Nov 1, 2016Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Jun 14, 2016

First Submission Date that Met QC Criteria

Jun 14, 2016

First Posted Date

Jun 17, 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

Oct 31, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of informed consent
Histologically confirmed stage IIIB/IV NSCLC.
Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

Exclusion Criteria:

Histologically confirmed small cell lung cancer or other metastatic tumors
Patient had received prior chemotherapy or EGFR-TKIs treatment
Patients who harbor Exon20 T790M mutation

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

NSCLC patients with activating EGFR mutations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunming Ding, Ph.D	Contact	86-755-86690871		cmdingchina@qq.com
Ju Luan, Ph.D	Contact	86-755-86690871		luanluanjuju@163.com

Overall Officials

Name	Affiliation	Role
Wenfeng Li, Ph.D	First Affiliated Hospital of Wenzhou Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wenzhou Medical University	Recruiting	Wenzhou	Zhejiang	325000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31691892	Derived	Yang Z, Li J, Hu Y, Chen M, Peng D, Zong D, Shang Q, Tao L, Zhao Y, Ni Y, Ye J, Xie Y, Yang L, Lin Q, Cai C, Xu N, Huang X, Dong X, Zhou Z, Yu Y, Shangguan Z, Xu Y, Ying W, Weng M, Yuan Z, Dong Z, Li J, Zheng Z, Pan J, Liu L, Ye J, Zhang Z, Li W, Zhu J, Jin S, Li Y, Ding C. Dynamics of Plasma EGFR T790M Mutation in Advanced NSCLC: A Multicenter Study. Target Oncol. 2019 Dec;14(6):719-728. doi: 10.1007/s11523-019-00682-0.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D001984	Bronchial Neoplasms
D002283	Carcinoma, Bronchogenic
D008171	Lung Diseases
D008175	Lung Neoplasms