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

• Sponsor: National Cancer Institute, Naples (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05818865
• Collaborator: (none)
• Enrollment: 47
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 27.3
• Patients Per Site: 23.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Malignant	Device: CLG	N/A

Detailed 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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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).
• Actual Study Start Date: Jan 18, 2021
• Actual Primary Completion Date: Mar 22, 2022
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

Secondary Outcome Measures

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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istitute Nazionale Tumori - Fondazione G. Pascale	Napoli		Italy
2	Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS	Napoli		Italy

Sponsors and Collaborators

• National Cancer Institute, Naples

Investigators

• Principal Investigator: Luigi Portella, IRCCS I.N.T. "G. Pascale"

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute, Naples
• ClinicalTrials.gov Identifier: NCT05818865
• Other Study ID Numbers: TRAP4MET; 50/20
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Apr 19, 2023