NCT07765316Toborzás még nem indult
Targeting Pathogenic Myelopoiesis in Pancreatic Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 17.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2026. aug. 11.
- Kezdés
- 2026. szept. 30.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- IRCCS San Raffaele
- Betegségek
- Hasnyálmirigyrák
- NCT-szám
- NCT07765316
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 100
- 2026. szept. 30. és az elsődleges befejezés (2027. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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