Targeting Pathogenic Myelopoiesis in Pancreatic Cancer (NCT07765316) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Targeting Pathogenic Myelopoiesis in Pancreatic Cancer
100 participantsStarted 2026-09-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
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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 invasi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and phenotype of circulating myeloid and progenitor cell populations
Timeframe: Baseline, prior to initiation of anti-tumor treatment
2
Transcriptional profiles of circulating myeloid cells and hematopoietic stem and progenitor cells
Timeframe: Baseline, prior to initiation of anti-tumor treatment