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Pancreatic Cancer Evolution Upon Treatment

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Sep 28, 2025 to Sep 28, 2027 Completion date: Dec 31, 2025 to Dec 31, 2027v5 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2027
  2. Notable Primary completion date: Sep 28, 2024 to Sep 28, 2025 Completion date: Dec 31, 2024 to Dec 31, 2025v4 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to Dec 31, 2025
  3. Notable Primary completion date: Feb 28, 2023 to Sep 28, 2024v3
  4. Notable Enrollment target: 20 to 80v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This project aims at evaluating the different subtypes of pancreatic cancer on EUS-tissue acquisition of pancreatic cancer patients, and their possible modifications throughout time. The study takes advantage of a systematic evaluation of pancreatic cancers through diagnostic EUS-guided fine needle biopsy (FNB) sampling of the mass performed during a restaging EUS. FNB samples represent a valuable source of cancer cells, both for the histological diagnosis and as the source of tumor macromolecules, including DNA and RNA. Study design This is a prospective study enrolling patients with non-metastatic pancreatic cancer who already underwent diagnostic EUS with tissue acquisition and rapid on-site evaluation (ROSE) by cytologist positive for pancreatic cancer, with a first sample acquired for diagnostic purposes and a second sample stored for RNA extraction acquired with the already approved protocol BIOGASTRO. As recommended by guidelines, patients will follow the standard pathway of treatment, being sent to chemotherapy and will then undergo restaging of the lesion and re-evaluation of vascular invasion by CT and EUS. During this second session of EUS a new specimen of the tumor will be sampled for diagnostic purposes, with a second pass undergoing for RNA extraction.
Trial Details
NCT Number NCT05195281
Lead Sponsor IRCCS San Raffaele
Conditions Pancreatic Cancer
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov