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

"Principle Test" for Isolation and Characterization of Cancer Cells (CTC)-CXCR4+ Circulating in Belotero Loaded With CXCL12 in Patients With Solid Neoplasms (Endometrium, Kidney, Glioblastoma, Colorectal, Ovary and Lung).

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Device: CLG

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 Type: Interventional
• Enrollment (Estimated): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
  • Napoli, Italy
    • Istitute Nazionale Tumori - Fondazione G. Pascale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age <18
• Refusal to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: device (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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Luigi Portella, IRCCS I.N.T. "G. Pascale"

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): March 22, 2022
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TRAP4MET; 50/20 (Other Identifier: IRCCS I.N.T. "G. Pascale")

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No