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

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.

• Diagnostic procedures (Diagnostic test): Acquisition of biological material for bio-photonic technology analysis

Primary outcomes

• Diagnostic Accuracy of the Biophotonic Nanoparticle-Enabled Laser Blood Test (LASERBLOOD) for Detection of Pancreatic Ductal Adenocarcinoma (PDAC) [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.

Secondary outcomes

• Sensitivity and Specificity of Fluorescence Lifetime (FL) Fingerprints for Pancreatic Ductal Adenocarcinoma (PDAC) Detection at Optimal Cut-off [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.
• Correlation Between Fluorescence Lifetime (FL) Fingerprints and Clinical Stage of Pancreatic Ductal Adenocarcinoma (PDAC) [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).
• Mean Fluorescence Lifetime (FL) Values of Nanoparticle-Protein Corona Complexes in Plasma Samples, by Diagnostic Group [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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

**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.