Evaluate EGFR Mutation Status and Impact Factors in North... | NCT02620657

Studies
Evaluate EGFR Mutation Status and Impact Factors in North China

NCT02620657

Sponsor

ying cheng

Status

Completed

Last Update Posted

Aug 2, 2019Actual

Enrollment

2,809Actual

Phase

Not provided

Conditions

Non-Small Cell Lung Cancer

Interventions

Non interventional study

Countries

Not provided

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Nov 8, 2017Actual

Completion Date

Nov 8, 2017Actual

First Submitted Date

Dec 1, 2015

First Submission Date that Met QC Criteria

Dec 1, 2015

First Posted Date

Dec 3, 2015Estimated

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

Aug 1, 2019

Last Update Posted Date

Aug 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Approximately 3000 advanced NSCLC patients, who fulfil the inclusion/exclusion criteria, will be recruited by 30 sites in North China.

Detailed Description

Approximately 3000 advanced NSCLC patients will be recruited , and the medical information of recruited patients must be recorded in the hospital electronic system from Jan 1st 2014 to Dec 31st 2014 .The study will focus on the EGFR testing rate in adenocarcinoma patients，so the collecting data for non-adenocarcinoma patients will be controlled in less than 10% for each site.

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

2,809Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non interventional study		The patients with advanced NSCLC who have the medical records from Jan 1st 2014 to Dec 31st 2014 will be recruited .	Other: Non interventional study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non interventional study	Other	Non interventional study	Non interventional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To investigate the proportion of advanced NSCLC patients who performed EGFR mutation test		2014.01.01-2014.12.31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological confirmed NSCLC;
Patients were diagnosed with advanced NSCLC from Jan 1st 2014 to Dec 31st 2014;
Researchers should collect the records of consecutive NSCLC patients in each site.

Exclusion Criteria:

Any patients without NSCLC diagnosis;
Any patients which were diagnosed with advanced NSCLC before Jan 1st 2014 or after Dec 31st 2014.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

3000 advanced NSCLC patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CHENG NA Ying, Dr.	Jilin Provincial Tumor Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided