Gene Expression Profile of Resected Pancreatic and Ampullary Adenocarcinoma at Favorable Prognosis (NCT05754788) | Clinical Trial Compass
UnknownNot Applicable
Gene Expression Profile of Resected Pancreatic and Ampullary Adenocarcinoma at Favorable Prognosis
Italy40 participantsStarted 2022-09-19
Plain-language summary
The study aims at evaluating spatially resolved gene expression profiles of pancreatic and ampullary adenocarcinoma at favorable prognosis after surgical resection, in order to identify molecular features associated to a less aggressive biologic behavior that may benefit from upfront surgery.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
• Patients \>18 years old undergoing surgical treatment with curative intent for pancreatic and ampullary adenocarcinoma between 1/1/2010 and 31/12/2017 with a regular follow-up and a RFS ≥36 months including:
* Patients with locoregional lymph node metastases found at final pathology;
* Patients with residual microscopic disease found at final pathology (R1 resections);
* Presence of minimal extra-regional disease not detected pre-operatively (nodule of carcinosis, single liver metastasis, single extra-regional lymph node) and removed with the primary tumor within the same intervention.
Exclusion Criteria:
* Patients undergoing preoperative radiotherapy/chemotherapy for borderline resectable or initially unresectable tumors converted to surgical resection;
* Patients with residual macroscopic disease after surgery (R1 resections);
* Patients with metastatic disease found at laparotomy and contraindicating surgical resection, including unknown liver metastases, peritoneal carcinomatosis, distant lymph node disease;
* Patients with unavailable follow-up or surgical samples for gene analysis.
What they're measuring
1
Favorable-prognosis gene expression pattern
Timeframe: 19/09/2022-29/09/2023
Trial details
NCT IDNCT05754788
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano