Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared (PROVEIR_1)

Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.

Study Overview

• Status: Recruiting
• Conditions: Vesicle
• Intervention / Treatment: Diagnostic test: sierological test

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Fabrizio Pizzolante, MD PhD; Phone Number: +390630151; Email: fabrizio.pizzolante@policlinicogemelli.it
• Study Contact Backup: Name: Gabriele Ciasca, Professor; Phone Number: +390630151; Email: gabriele.ciasca@unicatt.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • FPGemelliIRCCS
      • Contact: Fabrizio Pizzolante, MD PhD; Phone Number: +390630151; Email: fabrizio.pizzolante@policlinicogemelli.it
      • Contact: Gabriele Ciasca, Professor; Phone Number: +390630151; Email: gabriele.ciasca@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The target population of this study is divided into two groups: a) control group, 32 cirrhotic patients and b) oncology group, 32 patients diagnosed with hepatocellular carcinoma

Description

Inclusion

• 18 years old with a diagnosis of liver cirrhosis of different etiology
• 18 years old with a diagnosis of hepatocellular carcinoma

Exclusion

• Have not signed the informed consent
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GRUPPO CIRROSI; 32 soggetti uomini o donne, >18 anni con diagnosi di cirrosi epatica di differente eziologiA	Diagnostic test: sierological test; sierological test: circulant vescicles
GRUPPO HCC; 32 pazienti uomini o donne, con diagnosi di neoplasia primitiva del fegato	Diagnostic test: sierological test; sierological test: circulant vescicles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary endpoint	To evaluate the change in extracellular vesicle concentration between the control group and oncology group. The concentration of vesicles per ml of blood will be measured by frequency shift of the plasmonic resonance peak of gold nanostructures following immuno-capture of vesicles.	12 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Fabrizio Pizzolante, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: MICROVESCICLES; CIRRHOSIS; HCC; NANOSTRUCTURES.
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister
• Other Study ID Numbers: 5452

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No