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Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study

NCT04245644 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2024-03-12

No results posted yet for this study

Summary

The evidence on the value of aspirin, statins, metformin, beta-blocking ACE inhibitors agents as chemopreventive agents in patients with pancreatic ductal adenocarcinoma is limited.

The aim of this study is to assess whether regular use of aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents use, before diagnosis, after surgery and in neo-adjuvant treatment setting, can increase rate of disease-free survival (DFS) and overall survival (OS) in participants with pancreatic ductal adenocarcinoma. The secondary aim is to evaluate if there is any difference in terms of "chemoprevention" between aspirin, statins, metformin and beta-blocking as chemopreventive agents, and if their prolonged daily use can positively influence the chemopreventive action.

400 patients with the following inclusion criteria will be enrolled in 3 years:

1. cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the gland, with or without metastases in other sites
2. patient age between 18 and 90 years
3. any medicine or drug in the daily patient therapy
4. Patients undergone to primary chemoradiotherapy or surgical resection, followed by adjuvant therapy or preceded by neoadjuvant chemoradiotherapy, are included in the study Anamnestic, clinical and pathological data, included data on the aspirin, statins, metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents assumption will be collected during the first visit with the surgeon. A database managed by a dedicated data manager will be created to collect and analyse data.

Patients will be followed for at least 24 months The study will last overall 5 years.

Conditions

Interventions

BEHAVIORAL

use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, Statins

enrolled patients will be asked details regarding their daily drug use, before and after diagnosis of pancreatic cancer

Sponsors & Collaborators

  • Massimo Falconi

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-02
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245644 on ClinicalTrials.gov