Exploring genetic and immune factors in advanced pancreatic cancer
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
This study is trying to understand how genetic and immune factors affect treatment responses in patients with advanced pancreatic cancer to help personalize their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT05248750 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the complex interplay of genetic, stromal, and immunological factors in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). By analyzing tissue samples obtained through endoscopic ultrasound fine needle biopsy (EUS-FNB), the study aims to identify prognostic factors and understand how genetic heterogeneity affects treatment response and chemotherapy resistance. The findings could provide insights into personalized medicine approaches for managing this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a histological diagnosis of unresectable pancreatic ductal adenocarcinoma who are fit for chemotherapy.
Not a fit: Patients with histological diagnoses other than pancreatic ductal adenocarcinoma or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and tailored treatment strategies for patients with advanced pancreatic cancer.
How similar studies have performed: While the study's approach is innovative, similar studies focusing on genetic and immunological factors in pancreatic cancer have shown promise in understanding treatment responses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings * Availability of biopsies obtained during EUS-FNB * Histological diagnosis of pancreatic ductal adenocarcinoma of any stage * Patients must be fit for chemotherapy administration * They have to express their willingness to be followed up at our pancreatic high volume centers * Age \>18 and \<80 years * Able to sign informed consent Exclusion Criteria: * Histological diagnoses other than pancreatic ductal adenocarcinoma * Pregnancy or lactation
Where this trial is running
Rome, Lazio
- "Agostino Gemelli" Hospital, Catholic University of Sacred Heart — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Alberto Larghi, MD — Fondazione Policlinico Universitario Agostino Gemelli
- Study coordinator: Alberto Larghi, MD
- Email: alberto.larghi@yahoo.it
- Phone: +390630156580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.