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

NCT05818865 | Active Not Recruiting

• 2 other identifiers: TRAP4MET50/20
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

device (CLG)

OTHER

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

Interventions

CLG DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age \<18
• Refusal to sign informed consent

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (2)

Istitute Nazionale Tumori - Fondazione G. Pascale

Napoli, Italy

Location

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

Napoli, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Luigi Portella

  IRCCS I.N.T. "G. Pascale"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 19, 2023
• Study Start: January 18, 2021
• Primary Completion: March 22, 2022
• Study Completion: December 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

IT (2)