Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection

NCT ID: NCT00831454

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NON-SMALL-CELL LUNG CANCER

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Availability of tumor tissue or blood samples.
* Diagnosis of NSCLC
* At least one treatment with EGFR-TKIs inhibitors

Exclusion Criteria

* Other than NSCLC primary diagnosis
* No treatment with EGFR-TKIs inhibitors
* No archival tissue available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Armando Santoro, MD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Armando Santoro, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istituto Clinco Humanitas

Rozzano, Mialno, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONC/OSS-02/2008

Identifier Type: -

Identifier Source: org_study_id