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Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma

C

Catholic University of the Sacred Heart

Status

Enrolling

Conditions

Pancreas Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05248750
PDAC AIRC

Details and patient eligibility

About

Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
  • Availability of biopsies obtained during EUS-FNB
  • Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
  • Patients must be fit for chemotherapy administration
  • They have to express their willingness to be followed up at our pancreatic high volume centers
  • Age >18 and <80 years
  • Able to sign informed consent

Exclusion criteria

  • Histological diagnoses other than pancreatic ductal adenocarcinoma
  • Pregnancy or lactation

Trial contacts and locations

1

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Central trial contact

Alberto Larghi, MD; Carolina Gualtieri

Data sourced from clinicaltrials.gov

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