Pathomolecular Analysis of Rare EGFR Mutations in Advance... | NCT01215474

Studies
Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC

NCT01215474

Sponsor

Provitro GmbH

Status

Completed

Last Update Posted

Jun 16, 2011Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Mutations in Exons 18 to 21

Interventions

Not provided

Countries

Germany

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 2010

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 5, 2010

First Submission Date that Met QC Criteria

Oct 5, 2010

First Posted Date

Oct 6, 2010Estimated

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

Jun 15, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Name	Class
AstraZeneca	INDUSTRY
Charite University, Berlin, Germany	OTHER

Description Module

Brief Summary

While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).

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

500Actual

Label	Type	Description	Intervention Names
NSCLC Stadium III-IV

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NSCLC Stadium III-IV

Exclusion Criteria:

no NSCLC or different stadium

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

Patients who were biopsied and/or received surgery for NSCLC diagnostics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Pathology, Charité University Medicine Berlin		Berlin		10117	Germany