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

June 16, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy
      • Rome, Italy, Italy, 00128
        • Recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DIAGNOSTIC
Acquisition of biological material for bio-photonic technology analysis
Diagnostic test: Diagnostic procedures
Acquisition of biological material for bio-photonic technology analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of the Biophotonic Nanoparticle-Enabled Laser Blood Test (LASERBLOOD) for Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of Fluorescence Lifetime (FL) Fingerprints for Pancreatic Ductal Adenocarcinoma (PDAC) Detection at Optimal Cut-off
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67.24CET2CBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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