Targeting Pathogenic Myelopoiesis in Pancreatic Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Ability and willingness to autonomously provide written informed consent.

Clinical diagnosis of non-metastatic pancreatic ductal adenocarcinoma (PDAC).

Treatment-naïve status at the time of blood collection, with no prior chemotherapy, radiotherapy, or immunotherapy for PDAC.

Disqualifiers

Inability to autonomously provide informed consent.

Failure to meet the inclusion criteria for the PDAC cohort.

Presence of severe comorbidities that, in the investigator's opinion, may interfere with study participation or interpretation of study results.

Previous systemic anti-cancer treatment for PDAC.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Treatment-naïve PDAC patients
Group B: Age-matched IPMN control patients

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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