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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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