Clinical trial · Observational

Targeting Pathogenic Myelopoiesis in Pancreatic Cancer

NCT07765316CI-TRIAL-00122403PaMPanot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Diseases	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Treatment-naïve PDAC patients
description
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
label
Age-matched IPMN control patients
description
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.

Primary outcomes (2)

measure
Frequency and phenotype of circulating myeloid and progenitor cell populations
timeFrame
Baseline, prior to initiation of anti-tumor treatment
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria

* For all participants:
* Age ≥18 years.
* Ability and willingness to autonomously provide written informed consent.
* For the PDAC cohort:
* 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.
* Newly diagnosed non-metastatic pancreatic cancer eligible for multimodal treatment.
* Candidate for standard clinical management at IRCCS Ospedale San Raffaele.
* For the age-matched control cohort:
* Patient followed at the Pancreatic Cystic Lesion outpatient clinic of IRCCS Ospedale San Raffaele.
* Diagnosis of intraductal papillary mucinous neoplasm (IPMN) under surveillance, with no evidence of pancreatic malignancy at the time of enrollment.
* Age within ±5 years of the corresponding PDAC cohort to allow age-matched comparator analyses.
* Exclusion Criteria
* For all participants:
* Inability to autonomously provide informed consent.
* For the PDAC cohort:
* 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.
* Use of anti-inflammatory drugs, including NSAIDs or immunomodulators.
* Events or conditions affecting inflammatory parameters, including acute inflammatory or infectious events such as cholangitis, jaundice, or recent invasive procedures.
* Hematologic diseases.
* Clinically significant hematological abnormalities that may interfere with immune profiling analyses, as assessed by the investigator.
* For the age-matched control cohort:
* Any acute or chronic inflammatory condition or ongoing infection.
* Any history of cancer or immunological disorders.

References

Publications (0)

Data not yet available

No reference posted for this study.