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

Not Applicable

Active, not recruiting

• Conditions: Neoplasm Malignant
• Interventions: Device: CLG

• Registration Number: NCT05818865
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-01-18
• Primary Completion: 2022-03-22
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Age ≥18
• Signature of Informed Consent
• Advanced solid neoplasm with metastases

Exclusion Criteria

• Age <18
• Refusal to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
device (CLG)	CLG	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.

Primary Outcome Measures

Name	Time	Method
In vitro isolation of CTCs.	2 years	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
Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers	2 years	Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR.

Secondary Outcome Measures

Name	Time	Method
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.	2 years	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.

Trial Locations

Locations (2)

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS; 🇮🇹 Napoli, Italy

Istitute Nazionale Tumori - Fondazione G. Pascale; 🇮🇹 Napoli, Italy