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Active, not recruiting Not applicable

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

NCT05818865 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-01-18
Last updated
2025-07-29

Condition(s) studied

Neoplasm Malignant

Investigational drug(s) / intervention(s)

CLG

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 * Signature of Informed Consent * Advanced solid neoplasm with metastases Exclusion Criteria: * Age \<18 * Refusal to sign informed consent

Primary outcome measure(s)

  • In vitro isolation of CTCs. — 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
  • Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers — 2 years
    Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR.

Trial sites (2)

FacilityCityRegionStatus
Istitute Nazionale Tumori - Fondazione G. Pascale Naples Italy
Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS Naples Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05818865 on ClinicalTrials.gov ↗ ← All trials in Italy