ClinicalTrials.gg
CompletedNCT00831454Updated Dec 2, 2014

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

An observational study in NON-SMALL-CELL LUNG CANCER, sponsored by Armando Santoro, MD. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by Armando Santoro, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
51
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • NON-SMALL-CELL LUNG CANCER
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In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 51 is below the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Armando Santoro, MD is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
51 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

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

    Time frame: At the end of enrollment

Secondary outcomes

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

    Time frame: At the end of enrollment

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Study locations

1 site
  • Istituto Clinco Humanitas
    Rozzano, Mialno 20089, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00831454
Lead sponsor
Armando Santoro, MD
Responsible party
Armando Santoro, MD (MD, Istituto Clinico Humanitas) — Sponsor-investigator
First posted
Jan 29, 2009
Start date
Sep 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Dec 2, 2014

Study contacts

Armando Santoro, MD
principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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