An observational study in Pancreatic Neuroendocrine Tumor, sponsored by Massimo Falconi. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Massimo Falconi · Observational
Among 11 studies in Adenoma, Islet Cell with a site in Italy — 3 open to participants now, 6 under way, 1 of them phase 3. Adenoma, Islet Cell · Italy.
Among the 11 studies in Adenoma, Islet Cell with a site in Italy, this one is the only one that started in 2026, is one of 6 observational ones, and was the 11th registered.
113 studies on the registry are indexed under Adenoma, Islet Cell; 30 are open to participants now.
Browse Adenoma, Islet Cell studies →3 of the 11 studies in Adenoma, Islet Cell with a site in Italy are open now. Recruiting first, the newest first:
Exelixis · Sites in Italy, United States, Australia and 15 more countries
Ages 18+
IRCCS San Raffaele · Sites in Italy
Ages 18+
Merck Sharp & Dohme LLC · Sites in Italy, United States, Australia and 19 more countries
Ages 12+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 24 Adenoma, Islet Cell studies recruiting now, 17 (71%) set no upper age limit and 2 (8%) stop at 75 or younger; 2 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 1
First in 2006; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 70 across 31 observational studies indexed under Adenoma, Islet Cell.
Median enrollment 160 across the 5 interventional studies, 70 across the 6 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
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3 of 11 have an industry lead sponsor. The 10 most frequent:
Massimo Falconi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Massimo Falconi has 1 study filed under Adenoma, Islet Cell — fewer than ten, so there is no comparison to draw.
1 of the studies in Adenoma, Islet Cell with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07817225Massimo FalconiOptimizing Risk Assessment Through cfDNA in Pancreatic Neuroendocrine Tumors for Clinical Evaluation | 2027-09-12 |
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Among the 11 studies in Adenoma, Islet Cell with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are heterogeneous neoplasms of the pancreatic endocrine tissue, displaying variable clinical behavior from indolent to highly aggressive forms. Their often asymptomatic nature and lack of reliable preoperative biomarkers make clinical management particularly challenging.
This exploratory study will investigate cell-free DNA (cfDNA) as a potential non-invasive biomarker in NF-PanNETs. cfDNA samples from approximately 30 patients, representing distinct clinical courses (active surveillance, indolent post-surgical, and aggressive post-surgical cases), will be analyzed using advanced methylome and nucleosome footprinting techniques.
The aim is to evaluate cfDNA's diagnostic and prognostic potential to improve disease monitoring and support personalized therapeutic strategies in NF-PanNET patients.
Pancreatic neuroendocrine tumors (PanNETs) are rare, heterogeneous neoplasms arising from the endocrine tissue of the pancreas. Non-functioning pancreatic neuroendocrine tumors (NF- PanNETs) have traditionally been considered rare; however, their reported incidence has significantly increased over the past two decades. Current estimates suggest that approximately 1-5% of the general population may harbor undiagnosed NF-PanNETs. Given this prevalence, there is an increasing need for reliable diagnostic tools to distinguish high-risk, aggressive tumors from benign, indolent lesions.
NF-PanNETs exhibit a wide spectrum of biological behavior, ranging from slow-growing, indolent tumors to highly aggressive variants prone to local invasion and distant metastases. However, due to their frequent asymptomatic presentation and the absence of reliable preoperative markers for tumor aggressiveness, clinical management remains challenging. Current diagnostic methods rely on imaging and invasive biopsies. However, this approach has limitations in detecting early-stage disease and assessing tumor dynamics. Indeed, it often leads to overtreatment in low-risk patients through unnecessary surgical interventions, while potentially undertreating those who might benefit from more aggressive therapeutic strategies, such as neoadjuvant therapy.
In recent years, cell-free DNA (cfDNA) has emerged as a promising non-invasive biomarker in the oncology setting, proving to be extremely useful for diagnosis, prognosis and therapeutic purposes.
In the specific context of PanNETs, there is limited research on the value of cfDNA. Despite showing encouraging results, the few existing investigations on this subject, have included only small and heterogeneous cohorts, varying primary tumor sites, stages and differentiation status.
This exploratory study will analyze cfDNA profiles from approximately 30 NF-PanNET patients (10 under active surveillance, 10 with indolent tumors post-surgery, and 10 with aggressive tumors post-surgery) using advanced methylome and nucleosome footprinting technologies. Analyses in the three patient subgroups will be compared with data from a previously characterized cohort of healthy subjects.
The goal is to assess cfDNA's diagnostic and prognostic utility, potentially offering a non-invasive tool for better disease management, monitoring and personalized patient care.
The study population will include approximately 30 adult patients diagnosed with non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) whose biological samples are available through the HSR NETBank biobank. Participants will represent three distinct clinical subgroups: patients under active surveillance and patients who underwent surgical resection with a histopathological diagnosis of either indolent or aggressive disease. All included patients have provided informed consent for the use of their biological material and clinical data for research purposes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of indolent disease
Other: cfDNA molecular profiling
patients submitted to surgical resection for pancreatic neuroendocrine tumor (PanNET) with histopathological diagnosis of aggressive disease
Other: cfDNA molecular profiling
patients currently under active surveillance for small indolent pancreatic neuroendocrine tumor (PanNET)
Other: cfDNA molecular profiling
Circulating-free DNA (cfDNA) will be extracted from plasma samples previously collected and currently stored at the San Raffaele Hospital (HSR) NETBank biobank. cfDNA profiling will be performed using methylome and nucleosome footprinting techniques. No therapeutic or experimental intervention will be performed.
cfDNA Molecular Profiling
To investigate the feasability of circulating-free DNA (cfDNA) assessment as a non- invasive biomarker for non-functioning pancreatic neuroendocrine tumors (NF-PanNETs). cfDNA concentrations and cfDNA epigenetic and fragmentomic signatures in plasma samples will be analysed.
Time frame: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
Predictive Value of cfDNA for Tumor Aggressiveness
To correlate circulating-free DNA (cfDNA) levels with tumor aggressiveness and clinical outcomes, and to identify tissue-of-origin insights using cfDNA methylation and nucleosomal footprints.
Time frame: From enrollment until the day before surgery, or during scheduled visits for patients under active surveillance.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Massimo Falconi