Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2021-07-14
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Repetition of EUS-FNA or FNB for RNA extraction
Fine Needle Biopsy or Aspiration
A new sampling of the tumor will be performed after 4-6 months of neoadjuvant chemotherapy
Interventions
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Fine Needle Biopsy or Aspiration
A new sampling of the tumor will be performed after 4-6 months of neoadjuvant chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Willing to sign informed consent
* Patient with CT scan or MRI or EUS defining the lesion as locally advanced
* Patient who already underwent EUS-TA for solid lesion of the pancreas positive for pancreatic ductal adenocarcinoma (PDAC)
* Patient undergoing neoadjuvant chemotherapy
* Patient primarily followed at San Raffaele Hospital
Exclusion Criteria
* Pregnancy and breastfeeding
* Cytology positive for malignancies other than PDAC
* Patient undergoing progression at re-staging CT scan
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Gabriele Capurso
Chief of Clinical Research, PancreatoBiliary Endoscopy and EUS Division, Deputy Director of Pancreas Center
Locations
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IRCCS San Raffaele Hospital
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Livia Archibugi, MD
Role: primary
Other Identifiers
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PACEUT
Identifier Type: -
Identifier Source: org_study_id