Clinical trial · Observational
Pancreatic Cancer Lifestyle Evolution And Resistance
Decoding Environmental Drivers of Adaptive Evolution and Chemotherapy Resistance in Advanced Pancreatic Cancer
- 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)
Advanced PDAC patients undergo polychemotherapy, yet responses are highly variable. Transcriptome signatures are emerging as key predictors of treatment response. However, PDAC adapts across sites (primary vs. metastases) and evolves under treatment pressure (pre- vs. post-chemotherapy). Moreover, common environmental pollutants, like smoking and microplastics, contribute to carcinogenesis, yet their impact on PDAC evolution and treatment response remains unclear. To fill these gaps, the CLEAR project aims at investigating: 1. transcriptome patterns linked to treatment response; 2. effects of smoking and microplastic exposure on treatment outcomes; 3. PDAC evolution across organ sites and under chemotherapy. These studies will help uncover biomarkers and factors shaping disease progression, hence paving the ground for personalized therapies.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound with FNA/FNB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with pancreatic adenocarcinoma
- description
- The study population consists of adult patients (aged ≥18 years) with a clinical and/or radiological suspicion of Pancreatic Ductal Adenocarcinoma (PDAC) who are scheduled to undergo a diagnostic Endoscopic Ultrasound-guided Tissue Acquisition (EUS-TA) as part of their standard clinical pathway. The population will include both men and women, without restrictions on ethnicity. Including a 10% loss to follow-up, the planned cohort is 150 patients, evenly distributed among the three regimens (mFOL, NG or PAXG).
- interventionNames
- Procedure: Endoscopic Ultrasound with FNA/FNB
Primary outcomes (2)
- measure
- Response to treatment at 6 months
- timeFrame
- 6 months
- description
- Response to treatment assessed every 3 months by RECIST 1.1 criteria and defined as Disease Control Rate at 6 months (DCR-6)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age = 18 years * Willing to sign informed consent * Patient with CT scan or MRI or EUS with a lesion suspect of PDAC at any clinical stage * Patients considered fit to receive polychemotherapy with either mFOL, NG or PAXG. * Patients primarily followed at HSR Exclusion Criteria: * Patients not willing to sign informed consent * Pregnancy and breastfeeding * Cytology positive for malignancies other than PDAC * Patients who have not performed biopsy for safety or technical reasons * Patients unfit for polychemotherapy
References
Publications (3)
- BACKGROUNDReni M, Macchini M, Orsi G, Procaccio L, Malleo G, Carconi C, Rapposelli IG, Bencardino K, Scartozzi M, Balzano G, Tamburrino D, Merelli B, Sperti E, Belfiori G, Liscia N, Bozzarelli S, Di Marco M, Tamburini E, Milella M, Lonardi S, Ercolani G, Mazzola M, Palumbo D, Torri V, Falconi M. Preoperative mFOLFIRINOX versus PAXG for stage I-III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 x 2 factorial phase 3 trial. Lancet. 2026 Dec 20;406(10522):2945-2956. doi: 10.1016/S0140-6736(25)01685-X. Epub 2025 Nov 20. PMID 41275879
- BACKGROUNDPanzeri V, Manni I, Capone A, Naro C, Sacconi A, Di Agostino S, de Latouliere L, Montori A, Pilozzi E, Piaggio G, Capurso G, Sette C. The RNA-binding protein MEX3A is a prognostic factor and regulator of resistance to gemcitabine in pancreatic ductal adenocarcinoma. Mol Oncol. 2021 Feb;15(2):579-595. doi: 10.1002/1878-0261.12847. Epub 2020 Nov 24. PMID 33159833
- BACKGROUNDArchibugi L, Ruta V, Panzeri V, Redegalli M, Testoni SGG, Petrone MC, Rossi G, Falconi M, Reni M, Doglioni C, Sette C, Arcidiacono PG, Capurso G. RNA Extraction from Endoscopic Ultrasound-Acquired Tissue of Pancreatic Cancer Is Feasible and Allows Investigation of Molecular Features. Cells. 2020 Nov 30;9(12):2561. doi: 10.3390/cells9122561. PMID 33266052