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Active, Not Recruiting

NCT Number: NCT05818865

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neoplasm Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istitute Nazionale Tumori - Fondazione G. Pascale, Naples, Italy

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18
  • Refusal to sign informed consent

Treatment and study plan

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.

Primary outcomes

  1. In vitro isolation of CTCs.

    Time frame: 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

  2. Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers

    Time frame: 2 years

    Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR.

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study 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).

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Apr 19, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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