An observational study in Pancreatic Diseases, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by IRCCS San Raffaele · Observational
This prospective observational study aims to investigate pathogenic myelopoiesis in patients with pancreatic ductal adenocarcinoma (PDAC) and to characterize the systemic immune alterations associated with tumor-related inflammation.
The study will enroll 50 patients with newly diagnosed, non-metastatic, treatment-naïve PDAC and 50 age-matched control patients with intraductal papillary mucinous neoplasm (IPMN) under surveillance and no evidence of pancreatic malignancy. Control patients will be matched to PDAC patients by age within a range of ±5 years whenever feasible.
A single peripheral blood sample will be collected at baseline from all participants. In PDAC patients, blood collection will be performed before initiation of any anti-tumor treatment. Translational analyses will characterize circulating myeloid cells, progenitor cells, and hematopoietic stem and progenitor cell-related transcriptional programs using high-dimensional flow cytometry and single-cell transcriptomic analyses.
The primary objective is to identify the molecular drivers of pathogenic myelopoiesis in PDAC by assessing quantitative and qualitative differences between PDAC patients and age-matched controls in circulating myeloid and progenitor cell populations and their transcriptional profiles. The study will specifically explore the hypothesis that IL-1β-associated tumor inflammation contributes to systemic reprogramming of hematopoietic progenitor compartments and promotes myeloid-biased hematopoiesis.
PDAC patients will also be followed clinically for 12 months using data derived from routine clinical practice to explore associations between baseline pathogenic myelopoiesis-related profiles and subsequent clinical outcomes. No follow-up is required for control patients.
Pancreatic ductal adenocarcinoma (PDAC) is characterized by a highly inflammatory and immunosuppressive tumor microenvironment. During cancer progression, tumor-derived inflammatory signals can alter hematopoiesis and promote the expansion of myeloid cells with pro-tumorigenic functions. Inflammatory cytokines, including interleukin-1 beta (IL-1β), may act on hematopoietic stem and progenitor cells (HSPCs), inducing genomic and metabolic reprogramming and favoring myeloid-biased hematopoiesis. Previous and preliminary findings suggest that IL-1β may contribute to pathogenic inflammation in PDAC and to systemic conditioning of the immune system. The study hypothesis is that IL-1β-associated tumor inflammation reprograms hematopoietic progenitor compartments, leading to persistent generation of pro-inflammatory myeloid cells that may contribute to PDAC progression and recurrence.
This is a monocentric, prospective observational cohort study designed to characterize pathogenic myelopoiesis in patients with PDAC. The study will include 50 patients with newly diagnosed, non-metastatic, treatment-naïve PDAC and 50 age-matched control patients. Control patients will be recruited among individuals with intraductal papillary mucinous neoplasm (IPMN) under surveillance at the Pancreatic Cystic Lesion outpatient clinic, with no evidence of pancreatic malignancy at enrollment. Controls will be selected to match the age of PDAC patients within a range of ±5 years whenever feasible.
The primary objective is to identify the molecular drivers of pathogenic myelopoiesis in PDAC patients. At baseline, quantitative and qualitative differences between PDAC patients and age-matched controls will be evaluated in the frequency and phenotype of circulating myeloid and progenitor cell populations using high-dimensional flow cytometry. Transcriptional profiles of circulating myeloid cells and HSPCs will also be characterized, including differentially expressed genes, gene ontology annotations, and gene regulatory networks.
After informed consent and verification of eligibility criteria, demographic and relevant clinical data will be collected. All participants will undergo a single peripheral blood collection of approximately 14 mL specifically for research purposes. In PDAC patients, blood will be collected at baseline before initiation of any anti-tumor treatment. Control patients will undergo the same baseline blood sampling for comparator translational analyses. Peripheral blood sampling is the only study-specific procedure; no investigational medicinal products or therapeutic interventions will be administered as part of the study.
Blood samples will undergo translational laboratory analyses aimed at characterizing circulating myeloid cells, progenitor cells, and HSPC-related transcriptional programs. Planned analyses include high-dimensional flow cytometry and transcriptomic and epigenetic analyses. Biological samples will be processed according to established laboratory procedures and used exclusively for the analyses described in the study protocol.
In addition to the human translational component, the research project includes experimental studies aimed at investigating the persistence and molecular determinants of IL-1β-induced reprogramming of bone marrow progenitor cells. In mouse models, the persistence of IL-1β-dependent reprogramming will be evaluated through characterization of circulating and bone marrow myeloid populations, transcriptional profiles, and tumor growth following experimental tumor challenge. Exploratory analyses will investigate transcriptional and epigenetic programs associated with IL-1β-induced inflammatory memory, including differential gene expression, chromatin accessibility, histone modifications, and transcription factor regulatory programs. Candidate mechanisms identified experimentally will be evaluated in relation to IL-1β-dependent signatures detected in circulating monocytes from PDAC patients compared with age-matched controls.
PDAC patients will be followed clinically for 12 months after enrollment. No additional protocol-mandated visits or procedures are required during follow-up. Clinical information will be obtained exclusively from routine standard-of-care visits and medical records and will include, where available, treatments received, disease status, recurrence, progression, and survival. These data will be used to explore associations between baseline pathogenic myelopoiesis-related profiles and subsequent clinical outcomes. Control patients will not undergo study-specific follow-up after baseline assessment.
Statistical analyses will primarily be descriptive and exploratory. Baseline biological features will be compared between PDAC patients and age-matched controls using appropriate parametric or non-parametric statistical methods and bioinformatic approaches for high-dimensional datasets. Associations between baseline biological features and clinical outcomes will also be explored within the PDAC cohort.
The planned enrollment period is 2 years. PDAC patients will participate in clinical follow-up for 12 months, while control patients will undergo baseline assessment only. The overall study duration is expected to be 3 years.
184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.
This study's planned enrollment of 100 is below the median of 363 across 76 observational studies indexed under Pancreatic Diseases.
Browse Pancreatic Diseases studies →IRCCS San Raffaele is the lead sponsor of 454 studies on the registry; 235 are open to participants now.
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The study population will include adults with newly diagnosed, non-metastatic, treatment-naïve pancreatic ductal adenocarcinoma (PDAC) evaluated at the Pancreatic Surgery Unit of IRCCS Ospedale San Raffaele, and age-matched control patients. Controls will be recruited among patients with intraductal papillary mucinous neoplasm (IPMN) under surveillance at the Pancreatic Cystic Lesion outpatient clinic, with no evidence of pancreatic malignancy at enrollment. Control patients will be selected to match the age of PDAC patients within ±5 years whenever feasible. The study will include 50 PDAC patients and 50 age-matched controls
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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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with newly diagnosed, non-metastatic pancreatic ductal adenocarcinoma (PDAC), enrolled before initiation of chemotherapy, radiotherapy, or immunotherapy. Participants will undergo a single 14 mL peripheral blood collection at baseline, prior to any anti-tumor treatment, for translational analyses including high-dimensional flow cytometry and single-cell transcriptomic profiling. Clinical follow-up data will be collected from routine clinical practice for 12 months
Adults with intraductal papillary mucinous neoplasm (IPMN) under surveillance and no evidence of pancreatic malignancy at enrollment, selected as age-matched controls for the PDAC cohort (within ±5 years whenever feasible). Participants will undergo a single 14 mL peripheral blood collection at baseline for comparator translational analyses. No study-specific follow-up is required for control participants.
Frequency and phenotype of circulating myeloid and progenitor cell populations
Quantitative and phenotypic differences in circulating myeloid and progenitor cell populations between treatment-naïve PDAC patients and age-matched control patients, assessed by high-dimensional flow cytometry
Time frame: Baseline, prior to initiation of anti-tumor treatment
Transcriptional profiles of circulating myeloid cells and hematopoietic stem and progenitor cells
Differences in transcriptional profiles of circulating myeloid cells and hematopoietic stem and progenitor cells (HSPCs) between treatment-naïve PDAC patients and age-matched control patients, including differentially expressed genes, gene ontology annotations, and gene regulatory networks.
Time frame: Baseline, prior to initiation of anti-tumor treatment
IL-1β-associated transcriptional signatures in circulating monocytes
Presence and differential expression of IL-1β-associated transcriptional signatures in circulating monocytes from treatment-naïve PDAC patients compared with age-matched control patients, as part of the validation of candidate regulators of IL-1β-induced inflammatory memory
Time frame: Baseline, prior to initiation of anti-tumor treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 44 observational studies under Pancreatic Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 119. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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