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Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer (LASERBLOOD)

16. juni 2026 opdateret af: Fondazione Policlinico Universitario Campus Bio-Medico
LASERBLOOD is based on a biophotonic technology that can be used to predict the development of Pancreatic Ductal Adenocarcinoma (PDAC) in particular categories of subjects at risk (e.g. persons with diabetes, obese people, patients with Intraductal Papillary Mucinous Neoplasm [IPMN] or other cystic diseases of the pancreas, etc.) and at the same time offer the possibility of verifying the real effectiveness of the treatments to which affected patients are subjected.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

LASERBLOOD is based on a biophotonic technology that can be used to predict the development of Pancreatic Ductal Adenocarcinoma (PDAC) in particular categories of subjects at risk (e.g. persons with diabetes, obese people, patients with Intraductal Papillary Mucinous Neoplasm [IPMN] or other cystic diseases of the pancreas, etc.) and at the same time offer the possibility of verifying the real effectiveness of the treatments to which affected patients are subjected.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • Italy
      • Rome, Italy, Italien, 00128
        • Rekruttering
        • Fondazione Policlinico Universitario Campus Bio-medico
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

**Inclusion criteria for patients with PDAC and IPMN:**

  • No history of prior neoplastic diseases;
  • Adequate renal and hepatic function;
  • No hematologic disorders;
  • Age ≥ 18 years;
  • No active infections;
  • Written informed consent.

**Exclusion criteria:**

  • Severe pre-existing medical conditions, such as serious illnesses or other medical conditions that could negatively affect study outcomes or pose a high risk to the patient's health;
  • Ongoing therapies that could interfere with the study or alter the results.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: DIAGNOSTIC
Acquisition of biological material for bio-photonic technology analysis
Diagnostisk test: Diagnostic procedures
Acquisition of biological material for bio-photonic technology analysis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diagnostic Accuracy of the Biophotonic Nanoparticle-Enabled Laser Blood Test (LASERBLOOD) for Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
Tidsramme: At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months
Area Under the Receiver Operating Characteristic Curve (AUC-ROC), with 95% confidence interval, of fluorescence lifetime fingerprints obtained by biophotonic laser analysis of nanoparticle-protein corona complexes in plasma, in discriminating subjects with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) from subjects without PDAC (including healthy controls and patients with Intraductal Papillary Mucinous Neoplasm [IPMN]). The reference standard is histopathological diagnosis (on surgical specimen or endoscopic ultrasound-guided fine-needle aspiration/biopsy [EUS-FNA/B]) for PDAC and IPMN, and radiological/clinical assessment for healthy controls.
At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensitivity and Specificity of Fluorescence Lifetime (FL) Fingerprints for Pancreatic Ductal Adenocarcinoma (PDAC) Detection at Optimal Cut-off
Tidsramme: At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months
Sensitivity and specificity (percentage, with 95% confidence intervals) of fluorescence lifetime fingerprints in discriminating subjects with PDAC from subjects without PDAC, calculated at the optimal cut-off value determined by Youden's J index from the ROC analysis. Reference standard: histopathological diagnosis (surgical specimen or EUS-FNA/B) for PDAC and IPMN, radiological/clinical assessment for healthy controls.
At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months
Correlation Between Fluorescence Lifetime (FL) Fingerprints and Clinical Stage of Pancreatic Ductal Adenocarcinoma (PDAC)
Tidsramme: At time of PDAC diagnosis (within 12 months from enrollment)
Spearman correlation coefficient (ρ), with 95% confidence interval, between fluorescence lifetime fingerprint values and clinical stage of PDAC at diagnosis, classified according to the 8th edition American Joint Committee on Cancer (AJCC) TNM staging system (Stage I-II: early disease; Stage III-IV: advanced disease).
At time of PDAC diagnosis (within 12 months from enrollment)
Mean Fluorescence Lifetime (FL) Values of Nanoparticle-Protein Corona Complexes in Plasma Samples, by Diagnostic Group
Tidsramme: At baseline (time of enrollment), prior to any treatment
Mean fluorescence lifetime values, in nanoseconds (ns), measured by biophotonic laser analysis of plasma samples incubated with nanoparticles, reported as mean ± standard deviation (SD) separately for each diagnostic group: Pancreatic Ductal Adenocarcinoma (PDAC), Intraductal Papillary Mucinous Neoplasm (IPMN), and healthy controls.
At baseline (time of enrollment), prior to any treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

21. maj 2025

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 67.24CET2CBM

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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