Predictive Biomarkers for Early Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)

NCT07709052 | Not Yet Recruiting

• 1 other identifier: RC 2025 - PDAC
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pancreatic ductal adenocarcinoma (PDAC) is one of the cancers with the poorest prognosis and is often diagnosed at an advanced stage, resulting in very low 5-year survival rates. Many PDACs arise from non-invasive precursor lesions that develop over years, including pancreatic intraepithelial neoplasia (PanIN) and intraductal papillary mucinous neoplasms (IPMN). Only a minority of pancreatic cystic lesions progress to invasive carcinoma, and current clinical and radiologic criteria have limited accuracy in predicting which patients are at high risk. This observational translational study will enroll adult patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm (IPMN, PanIN, or PDAC) at IRCCS "Saverio de Bellis". Residual tumor tissue not required for diagnostic purposes, and when available adjacent non-neoplastic tissue, will be collected, coded, and pseudonymized for molecular analyses. Tumor cells will be used to generate three-dimensional cultures (tumorspheres and organoids) and will undergo genomic characterization by next-generation sequencing, RNA-sequencing-based transcriptomic profiling, protein expression analyses, advanced imaging, and in-vitro drug response assays. The main goal is to identify and validate molecular biomarkers predictive of progression to PDAC, improve risk stratification of patients with pancreatic precursor lesions, and support the development of innovative precision medicine strategies.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC); Intraductal Papillary Mucinous Neoplasm of Pancreas; Pancreatic Intraepithelial Neoplasia

Keywords

PDAC; IPMN; PanIN

Outcome Measures

Primary Outcomes (1)

• Molecular biomarkers predictive of progression to pancreatic ductal adenocarcinoma (PDAC

  Identification of genomic, transcriptomic, and proteomic biomarkers associated with progression from pancreatic precursor lesions (IPMN, PanIN) to PDAC, based on NGS, RNA seq, protein expression assays, and advanced imaging in patient derived tumorspheres and organoids.

  Up to 36 months from surgery

Secondary Outcomes (3)

• Protein level validation of candidate biomarkers

  Up to 36 months from surgery

• Association between biomarker profiles and tumor progression

  Up to 36 months

• Establishment of patient derived organoid models for preclinical studies

  Up to 36 months

Study Arms (3)

IPMN Cohort

Adult patients undergoing pancreatic resection with histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN); residual tumor tissue and, when available, adjacent non neoplastic tissue will be collected for molecular analyses and organoid generation

PanIN Cohort

Adult patients undergoing pancreatic resection with histopathologic diagnosis of pancreatic intraepithelial neoplasia (PanIN); residual tissue will be used for genomic, transcriptomic, proteomic, and functional studies in patient derived models

PDAC Cohort

Adult patients undergoing pancreatic resection with histopathologic diagnosis of pancreatic ductal adenocarcinoma (PDAC); biospecimens will be processed for comprehensive molecular characterization and comparison with precursor lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients (≥18 years) referred to the IRCCS "Saverio de Bellis" for pancreatic surgical resection due to suspected pancreatic neoplasm. Eligible participants are those with a histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN), pancreatic intraepithelial neoplasia (PanIN), or pancreatic ductal adenocarcinoma (PDAC), with availability of residual tumor tissue not required for routine diagnostics and who have provided written informed consent for use of biological samples in translational research.

You may qualify if:

• Age ≥ 18 years.
• Patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm.
• Histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN), pancreatic intraepithelial neoplasia (PanIN), or pancreatic ductal adenocarcinoma (PDAC).
• Availability of residual tumor tissue from the surgical procedure not required for diagnostic purposes.
• Signed written informed consent for the use of biological samples for research purposes

You may not qualify if:

• Age \< 18 years.
• Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC.
• Absence of written informed consent.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Related Publications (5)

• Marsoner K, Haybaeck J, Csengeri D, Waha JE, Schagerl J, Langeder R, Mischinger HJ, Kornprat P. Pancreatic resection for intraductal papillary mucinous neoplasm- a thirteen-year single center experience. BMC Cancer. 2016 Nov 4;16(1):844. doi: 10.1186/s12885-016-2887-8.

  PMID: 27809876 BACKGROUND

• Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489.

  PMID: 40245290 BACKGROUND

• Muraki T, Jang KT, Reid MD, Pehlivanoglu B, Memis B, Basturk O, Mittal P, Kooby D, Maithel SK, Sarmiento JM, Christians K, Tsai S, Evans D, Adsay V. Pancreatic ductal adenocarcinomas associated with intraductal papillary mucinous neoplasms (IPMNs) versus pseudo-IPMNs: relative frequency, clinicopathologic characteristics and differential diagnosis. Mod Pathol. 2022 Jan;35(1):96-105. doi: 10.1038/s41379-021-00902-x. Epub 2021 Sep 13.

  PMID: 34518632 BACKGROUND

• Taherian M, Wang H, Wang H. Pancreatic Ductal Adenocarcinoma: Molecular Pathology and Predictive Biomarkers. Cells. 2022 Sep 29;11(19):3068. doi: 10.3390/cells11193068.

  PMID: 36231030 BACKGROUND

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

  PMID: 35020204 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Residual pancreatic tumor tissue and, when available, adjacent non-neoplastic tissue obtained during standard surgical resection and not required for diagnostic purposes. Fresh tissue is processed to isolate tumor cells and establish three-dimensional cultures (tumorspheres and organoids). Additional material is fixed in formalin and embedded in paraffin (FFPE) for histopathologic, immunohistochemical, and immunofluorescence analyses. DNA, RNA, and protein are extracted for genomic, transcriptomic, and proteomic studies.

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Raffaele Armentano, MD

  IRCCS "Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Armentano, MD

CONTACT

+390804994185; raffaele.armentano@irccsdebellis.it

Martina Lepore Signorile, Biologist

CONTACT

martina.lepore@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share