Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-28 @ 9:36 AM
Study NCT ID:
NCT06266195
Status:
UNKNOWN
Last Update Posted:
2024-02-20
First Post:
2023-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001768', 'term': 'Blister'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary endpoint', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MICROVESCICLES; CIRRHOSIS; HCC; NANOSTRUCTURES.'], 'conditions': ['Vesicle']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* 18 years old with a diagnosis of liver cirrhosis of different etiology\n* 18 years old with a diagnosis of hepatocellular carcinoma\n\nExclusion\n\n* Have not signed the informed consent\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06266195', 'acronym': 'PROVEIR_1', 'briefTitle': 'Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared', 'orgStudyIdInfo': {'id': '5452'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GRUPPO CIRROSI', 'description': '32 soggetti uomini o donne, \\>18 anni con diagnosi di cirrosi epatica di differente eziologiA', 'interventionNames': ['Diagnostic Test: sierological test']}, {'label': 'GRUPPO HCC', 'description': '32 pazienti uomini o donne, con diagnosi di neoplasia primitiva del fegato', 'interventionNames': ['Diagnostic Test: sierological test']}], 'interventions': [{'name': 'sierological test', 'type': 'DIAGNOSTIC_TEST', 'description': 'sierological test: circulant vescicles', 'armGroupLabels': ['GRUPPO CIRROSI', 'GRUPPO HCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Pizzolante, MD PhD', 'role': 'CONTACT', 'email': 'fabrizio.pizzolante@policlinicogemelli.it', 'phone': '+390630151'}, {'name': 'Gabriele Ciasca, Professor', 'role': 'CONTACT', 'email': 'gabriele.ciasca@unicatt.it', 'phone': '+390630151'}], 'facility': 'FPGemelliIRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'FABRIZIO PIZZOLANTE, MD PhD', 'role': 'CONTACT', 'email': 'fabrizio.pizzolante@policlinicogemelli.it', 'phone': '+390630151'}, {'name': 'Gabriele Ciasca, Professor', 'role': 'CONTACT', 'email': 'gabriele.ciasca@unicatt.it', 'phone': '+390630151'}], 'overallOfficials': [{'name': 'FABRIZIO PIZZOLANTE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}