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

National Cancer Institute, Naples

Status: Active, not recruiting

Conditions: Neoplasm Malignant

Treatments: Device: CLG

Study type: Interventional

Funder types: Other

Identifiers

NCT05818865

50/20 (Other Identifier)

TRAP4MET

Details and patient eligibility

About

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

Full 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).

Enrollment: 47 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Age <18
• Refusal to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

device (CLG)

Other group

Description:

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.

Treatment:

Device: CLG