DiabetesLASERBLOODNCT07659639
Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer
A study testing Diagnostic procedures in people with Diabetes and IPMN, Pancreatic, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, IPMN, Pancreatic, PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Diagnostic procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No history of prior neoplastic diseases;
- Adequate renal and hepatic function;
- No hematologic disorders;
- Age ≥ 18 years;
- No active infections;
- Written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
Damiano Caputo, MD, +3906225411257, d.caputo@policlinicocampus.it
About this study
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.
Read the 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.
- Being tested
- Diagnostic procedures
- Medical subject headings
- Diabetes Mellitus, Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDiagnostic test
Acquisition of biological material for bio-photonic technology analysis
| Study group | Role | What they receive |
|---|---|---|
| DIAGNOSTIC | Experimental | Acquisition of biological material for bio-photonic technology analysis Receives: Diagnostic Test: Diagnostic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Biophotonic Nanoparticle-Enabled Laser Blood Test (LASERBLOOD) for Detection of Pancreatic Ductal Adenocarcinoma (PDAC)
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.
Measured: At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months
Secondary outcomes (3)
Sensitivity and Specificity of Fluorescence Lifetime (FL) Fingerprints for Pancreatic Ductal Adenocarcinoma (PDAC) Detection at Optimal Cut-off
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.
Measured: 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)
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).
Measured: 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
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.
Measured: At baseline (time of enrollment), prior to any treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659639
- Sponsor's protocol ID
- 67.24CET2CBM
- Acronym
- LASERBLOOD
- Status last verified
- Apr 2026
- First submitted
- 21 May 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07659639
- Acronym / sponsor ID
- LASERBLOOD / 67.24CET2CBM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIAGNOSTIC | Experimental | Diagnostic Test: Diagnostic proceduresAcquisition of biological material for bio-photonic technology analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No history of prior neoplastic diseases;
- Adequate renal and hepatic function;
- No hematologic disorders;
- Age ≥ 18 years;
- No active infections;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic proceduresAcquisition of biological material for bio-photonic technology analysis | Diagnostic test | DIAGNOSTIC |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic procedures in people with Diabetes and IPMN, Pancreatic, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damiano Caputo, MD (+3906225418012, d.caputo@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.