"Principle Test" for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+.

N/AActive Not RecruitingNCT05818865

National Cancer Institute, Naples47 enrolled

Overview

This is multicentric, interventional, non farmacological and prospective study.

The new CLG platform, a prototype owned by IRCCS Pascale Institute, is able to reconstruct a PMN for the capture of CTCs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. The purpose of the study is to evaluate in vitro the effectiveness of CLG in the isolation, recovery and subsequent molecular characterization of CTCs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm Malignant

Interventions

CLGDEVICE

The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of "fake niche" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 * Signature of Informed Consent * Advanced solid neoplasm with metastases Exclusion Criteria: * Age \<18 * Refusal to sign informed consent

Locations (2)

Istitute Nazionale Tumori - Fondazione G. Pascale

Naples, Italy

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS

Naples, Italy

Outcomes

Primary Outcomes

In vitro isolation of CTCs.

In vitro isolation of CTCs with high metastatic capacity from peripheral blood through CLG.Gene expression analysis will be performed using 250ng RNA for nCounter FLEX Analysis System (NanoStringTechnologies). Panels analyzed include the PanCancer Pathways and the PanCancer Progression. The data will be analyzed using the nSolver analysis software version 3.0

Time frame: 2 years

Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers

Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR.

Time frame: 2 years

Secondary Outcomes

The correlation of the number and of biological/molecular characteristics of CTCs with the clinical/pathological characteristics of the patients in analysis and their prognosis.

Time frame: 2 years

Data from ClinicalTrials.gov

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