[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651893":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":21,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":29,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":10,"enrollmentInfo":33,"targetDuration":10,"studyType":36,"phases":10,"briefSummary":37,"conditions":38,"keywords":40,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":10},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Treatment-naïve PDAC patients",null,"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":13,"type":10,"description":14,"interventionNames":10},"Age-matched IPMN control patients","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.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Giulio Belfiori","CONTACT","0226437810","belfiori.giulio@hsr.it",{"type":22,"investigatorFullName":17,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","MD Surgeon","100651893","targeting-pathogenic-myelopoiesis-in-pancreatic-cancer-100651893",false,"NCT07765316","Targeting Pathogenic Myelopoiesis in Pancreatic Cancer","PaMPa","Inclusion Criteria\n\n* For all participants:\n* Age ≥18 years.\n* Ability and willingness to autonomously provide written informed consent.\n* For the PDAC cohort:\n* Clinical diagnosis of non-metastatic pancreatic ductal adenocarcinoma (PDAC).\n* Treatment-naïve status at the time of blood collection, with no prior chemotherapy, radiotherapy, or immunotherapy for PDAC.\n* Newly diagnosed non-metastatic pancreatic cancer eligible for multimodal treatment.\n* Candidate for standard clinical management at IRCCS Ospedale San Raffaele.\n* For the age-matched control cohort:\n* Patient followed at the Pancreatic Cystic Lesion outpatient clinic of IRCCS Ospedale San Raffaele.\n* Diagnosis of intraductal papillary mucinous neoplasm (IPMN) under surveillance, with no evidence of pancreatic malignancy at the time of enrollment.\n* Age within ±5 years of the corresponding PDAC cohort to allow age-matched comparator analyses.\n* Exclusion Criteria\n* For all participants:\n* Inability to autonomously provide informed consent.\n* For the PDAC cohort:\n* Failure to meet the inclusion criteria for the PDAC cohort.\n* Presence of severe comorbidities that, in the investigator's opinion, may interfere with study participation or interpretation of study results.\n* Previous systemic anti-cancer treatment for PDAC.\n* Use of anti-inflammatory drugs, including NSAIDs or immunomodulators.\n* Events or conditions affecting inflammatory parameters, including acute inflammatory or infectious events such as cholangitis, jaundice, or recent invasive procedures.\n* Hematologic diseases.\n* Clinically significant hematological abnormalities that may interfere with immune profiling analyses, as assessed by the investigator.\n* For the age-matched control cohort:\n* Any acute or chronic inflammatory condition or ongoing infection.\n* Any history of cancer or immunological disorders.","ALL","18 Years",{"count":34,"type":35},100,"ESTIMATED","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.\n\nThe 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.\n\nA 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.\n\nThe 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.\n\nPDAC 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.",[39],"Pancreatic Diseases",[41,42,43,44],"Pancreatic Ductal Adenocarcinoma","Pathogenic Myelopoiesis","Single-Cell Transcriptomics","High-Dimensional Flow Cytometry","NOT_YET_RECRUITING","2026-08-14",{"date":48,"type":49},"2026-08-17","ACTUAL",{"date":51,"type":35},"2026-09-30",{"date":53,"type":35},"2029-12-31",{"name":5,"class":6}]