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Trial Title:
"Principle Test" for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+.
NCT ID:
NCT05818865
Condition:
Neoplasm Malignant
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
CLG
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.
Arm group label:
device (CLG)
Summary:
This is multicentric, interventional, non farmacological and prospective study.
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18
- Signature of Informed Consent
- Advanced solid neoplasm with metastases
Exclusion Criteria:
- Age <18
- Refusal to sign informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istitute Nazionale Tumori - Fondazione G. Pascale
Address:
City:
Napoli
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS
Address:
City:
Napoli
Country:
Italy
Start date:
January 18, 2021
Completion date:
January 2025
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05818865
