VesiclePROVEIR_1NCT06266195
Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
An observational study of Vesicle, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vesicle
- What is being tested?
- sierological test
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2023to 28 Feb 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 18 years old with a diagnosis of liver cirrhosis of different etiology
- 18 years old with a diagnosis of hepatocellular carcinoma
Who cannot join
- Have not signed the informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
FPGemelliIRCCS
Rome, Lazio, 00168
Fabrizio Pizzolante, MD PhD, +390630151, fabrizio.pizzolante@policlinicogemelli.it
Gabriele Ciasca, Professor, +390630151, gabriele.ciasca@unicatt.it
About this study
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.
- Conditions
- Vesicle
- Being tested
- sierological test
- Keywords
- MICROVESCICLES; CIRRHOSIS; HCC; NANOSTRUCTURES.
- Medical subject headings
- Blister, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sierological testDiagnostic test
sierological test: circulant vescicles
| Study group | Role | What they receive |
|---|---|---|
| GRUPPO CIRROSI | 32 soggetti uomini o donne, >18 anni con diagnosi di cirrosi epatica di differente eziologiA Receives: Diagnostic Test: sierological test | |
| GRUPPO HCC | 32 pazienti uomini o donne, con diagnosi di neoplasia primitiva del fegato Receives: Diagnostic Test: sierological test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Mar 2023
- Primary completion31 Dec 2023
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VesicleStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FABRIZIO PIZZOLANTE, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266195
- Sponsor's protocol ID
- 5452
- Acronym
- PROVEIR_1
- Status last verified
- Apr 2023
- First submitted
- 21 Jul 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
- ClinicalTrials.gov ID
- NCT06266195
- Acronym / sponsor ID
- PROVEIR_1 / 5452
- Conditions
- Vesicle
- Keywords
- MICROVESCICLES; CIRRHOSIS; HCC; NANOSTRUCTURES.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRUPPO CIRROSI | – | Diagnostic Test: sierological test32 soggetti uomini o donne, >18 anni con diagnosi di cirrosi epatica di differente eziologiA |
| GRUPPO HCC | – | Diagnostic Test: sierological test32 pazienti uomini o donne, con diagnosi di neoplasia primitiva del fegato |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 18 years old with a diagnosis of liver cirrhosis of different etiology
- 18 years old with a diagnosis of hepatocellular carcinoma
Key exclusion criteria (2 listed)
- Have not signed the informed consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sierological testsierological test: circulant vescicles | Diagnostic test | GRUPPO CIRROSI, GRUPPO HCC |
Primary outcome
primary endpoint
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FABRIZIO PIZZOLANTE principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vesicle, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FABRIZIO PIZZOLANTE, MD PhD (+390630151, fabrizio.pizzolante@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.