Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic procedures.
- Who it may be relevant to
- Registry conditions: Diabetes, IPMN, Pancreatic, PDAC - Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Diagnostic test Diagnostic procedures
Acquisition of biological material for bio-photonic technology analysis
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
- 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)]
- 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]
Eligibility criteria
\*\*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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Campus Bio-Medico — Rome
Identifiers
NCT: NCT07659639 · 67.24CET2CBM