Clinical trial · Observational
Gene Expression Profile of Resected Pancreatic and Ampullary Adenocarcinoma at Favorable Prognosis
Identification of Gene Expression Profile Associated With Favorable Prognosis in Patients Undergoing Radical Surgery for Pancreatic and Ampullary Adenocarcinoma
NCT05754788CI-TRIAL-00066741unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Favorable-prognosis pancreatic adenocarcinoma
- description
- Patients experiencing favorable prognosis (defined as RFS≥60 months) following resection for pancreatic adenocarcinoma
- label
- Unfavorable-prognosis pancreatic adenocarcinoma
- description
- Patients experiencing unfavorable prognosis (defined as RFS\<12 months) following resection for pancreatic adenocarcinoma
Primary outcomes (1)
- measure
- Favorable-prognosis gene expression pattern
- timeFrame
- 19/09/2022-29/09/2023
- description
- Identification of DSP gene aberrations associated to favorable prognosis (≥60-month RFS) after radical surgery for pancreatic and ampullary adenocarcinoma, through comparison of prognostically favorable and unfavorable gene expression profiles found in different tumor and microenvironment compartments.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDTorres C, Grippo PJ. Pancreatic cancer subtypes: a roadmap for precision medicine. Ann Med. 2018 Jun;50(4):277-287. doi: 10.1080/07853890.2018.1453168. Epub 2018 Mar 22. PMID 29537309
- BACKGROUNDPihlak R, Weaver JMJ, Valle JW, McNamara MG. Advances in Molecular Profiling and Categorisation of Pancreatic Adenocarcinoma and the Implications for Therapy. Cancers (Basel). 2018 Jan 12;10(1):17. doi: 10.3390/cancers10010017. PMID 29329208
- BACKGROUNDSilvestris N, Brunetti O, Bittoni A, Cataldo I, Corsi D, Crippa S, D'Onofrio M, Fiore M, Giommoni E, Milella M, Pezzilli R, Vasile E, Reni M. Clinical Practice Guidelines for Diagnosis, Treatment and Follow-Up of Exocrine Pancreatic Ductal Adenocarcinoma: Evidence Evaluation and Recommendations by the Italian Association of Medical Oncology (AIOM). Cancers (Basel). 2020 Jun 24;12(6):1681. doi: 10.3390/cancers12061681. PMID 32599886