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

Neoplasm Malignant Clinical Trial

Official title:

"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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05818865
• Other study ID #: TRAP4MET
• Secondary ID: 50/20
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: January 2025
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age <18
• Refusal to sign informed consent

Related Conditions & MeSH terms

• Neoplasm Malignant
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Istitute Nazionale Tumori - Fondazione G. Pascale	Napoli
Italy	Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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