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Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling (2012/52)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02407327
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : February 5, 2018
Ministry of Health, Italy
Information provided by (Responsible Party):
Istituto Oncologico Veneto IRCCS

Brief Summary:
The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer .

Condition or disease
Advanced Non Small Cell Lung Cancer

Detailed Description:

The primary aim of the Project is to determine the percentage of CTC-positive patients and total CTC numbers in advanced NSCLC at baseline, before starting treatment.

To valuate CTC count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and CTC count depending on the type and schedule of treatment.

Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor specimen using standard sequencing.

In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total CTC counts.

Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase) signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will be quantified as previously 8.

Data obtained with the CTC assay will be correlated with common prognostic factors.

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Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trattamento Personalizzato Del Tumore NSCLC Avanzato: Potenziali Applicazioni Della Caratterizzazione Fenotipica e Molecolare Delle Cellule Tumorali Circolanti (CTC)
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change of CTC count during treatment and comparison with CT and PET [ Time Frame: 36 months ]

Biospecimen Retention:   Samples Without DNA
Whole blood.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • Age 18-80 years old, males or females;
  • Patients with NSCLC confirmed by histopathology or cytology;
  • Life expectancy > 6 months;
  • Patients are voluntary to participate and sign the informed contents

Exclusion Criteria:

  • Any condition which might hamper compliance to the schedule of assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02407327

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Istituto Oncologico Veneto
Padova, PD, Italy, 35128
Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Ministry of Health, Italy

PubMed ID:17575225

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Responsible Party: Istituto Oncologico Veneto IRCCS Identifier: NCT02407327     History of Changes
Other Study ID Numbers: GR-2010-2303193
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Istituto Oncologico Veneto IRCCS:
Circulating tumour cells in Advanced Non Small Cell Lung Cancer

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes