Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations. (IDENTIFY)

April 11, 2014 updated by: AstraZeneca

Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Study Overview

Status

Completed

Conditions

Detailed Description

Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Cordoba, Argentina
    - Research Site
  - La Rioja, Argentina
    - Research Site
  - Mendoza, Argentina
    - Research Site
  - San Luis, Argentina
    - Research Site
  - Santa Fe, Argentina
    - Research Site
  - Tucuman, Argentina
    - Research Site
- Buenos Aires
  - Bahia Blanca, Buenos Aires, Argentina
    - Research Site
  - Bolivar, Buenos Aires, Argentina
    - Research Site
  - Ciudad de Buenos Aires, Buenos Aires, Argentina
    - Research Site
  - Junin, Buenos Aires, Argentina
    - Research Site
  - La Plata, Buenos Aires, Argentina
    - Research Site
  - Lanus, Buenos Aires, Argentina
    - Research Site
  - Lomas de Zamora, Buenos Aires, Argentina
    - Research Site
  - Mar del Plata, Buenos Aires, Argentina
    - Research Site
- La Pampa
  - Santa Rosa, La Pampa, Argentina
    - Research Site
- Rio Negro
  - Gral. Roca, Rio Negro, Argentina
    - Research Site
- Santa Fe
  - Rosario, Santa Fe, Argentina
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from specialized sites; all the participating investigators will be oncologists.

Description

Inclusion Criteria:

Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
Patients under 1st line treatment against lung adenocarcinoma.

Exclusion Criteria:

Patients not having the information required by the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Control
Case

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival Time Frame: 12 months after the diagnosis of advanced disease	12 months after the diagnosis of advanced disease
Overall Survival Time Frame: 12 months after the diagnosis of advanced disease	12 months after the diagnosis of advanced disease
Number of hospitalizations Time Frame: 12 months after the diagnosis of advanced disease	12 months after the diagnosis of advanced disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria