Clinical trial NCT02407327: Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling
Official title: Trattamento Personalizzato Del Tumore NSCLC Avanzato: Potenziali Applicazioni Della Caratterizzazione Fenotipica e Molecolare Delle Cellule Tumorali Circolanti (CTC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Non Small Cell Lung Cancer
Keywords: Circulating tumour cells in Advanced Non Small Cell Lung Cancer
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2015-04-02
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of CTC count during treatment and comparison with CT and PET
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
Study officials:
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