A Study of Prevalence of EGFR Mutations in Participants W... | NCT02695849

Studies
A Study of Prevalence of EGFR Mutations in Participants With NSCLC

NCT02695849

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Jul 4, 2016Estimated

Enrollment

69Actual

Phase

Not provided

Conditions

Non-Small Cell Lung Cancer

Interventions

Not provided

Countries

Jordan

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 2016

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

Mar 2012

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Feb 25, 2016

First Submission Date that Met QC Criteria

Feb 25, 2016

First Posted Date

Mar 1, 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 1, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Description Module

Brief Summary

This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).

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

Not provided

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

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSCLC Participants		Participants with non-squamous NSCLC will be enrolled in this study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with EGFR mutations		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with types of EGFR mutations		Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent form signature
Jordanian male and female participants greater than or equal to (>=) 18 years of age
Histologically confirmed NSCLC
Not participating in a study that involves an investigational agent within 30 days prior to enrollment

Exclusion Criteria:

Other primary malignancy
Fine needle aspiration samples

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

Participants with non-squamous non-small cell lung cancer (NSCLC)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

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

Facility	Status	City	State	ZIP	Country	Contacts
		Amman		11941	Jordan