NCT00831454

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

January 28, 2009

Last Update Submit

November 27, 2014

Conditions

NON-SMALL-CELL LUNG CANCER

Outcome Measures

Primary Outcomes (1)

  • to evaluate the presence of EGFR- and AKT-DNA polymorphisms.

    At the end of enrollment

Secondary Outcomes (1)

  • to correlate the biological characteristics with clinical characteristics and survival data of patients.

    At the end of enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NON-SMALL-CELL LUNG CANCER patients treated with EGFR-TKIs

You may qualify if:

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

You may not qualify if:

  • Other than NSCLC primary diagnosis
  • No treatment with EGFR-TKIs inhibitors
  • No archival tissue available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinco Humanitas

Rozzano, Mialno, 20089, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples tissue samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

IT(1)