Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04245644 |
| Other study ID # |
CAOS |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2019 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
IRCCS San Raffaele |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Sample size and Population
This study is designed as a monocentric observational prospective study. In a recent study
[9] authors found that the use of low-dose aspirin before and after a diagnosis of pancreatic
cancer reduces of 32% the risk of recurrence (Hazard ratio HR=0.68, p<0.01). On the basis of
this study and considering that the effect of other drugs as chemopreventive agentsw will be
studies, the estimate required sample size to achieve 90% power to detect at least 28%
reduction in a hazard of the "drug users" group, by using a two-sided 0.05-level log-rank
test, is 400. Therefore, from February 2019 to February 2022, 400 patients with a diagnosis
of pancreatic ductal adenocarcinoma at any stage meeting the following inclusion criteria are
expected to be enrolled. Median follow-up is estimated to be 24 months after the first
disease diagnosis.
Data collection methods
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. The PI will be responsible of the data
security.
Statistical analysis
Association between variables will be assessed using the Chi Squared test (or Fisher's exact
text where appropriate) for categorical variables and the Spearman's correlation for scale
variables. DFS and OS will be estimated using Kaplan-Mayer method and Log Rank tests will be
used to evaluate the difference between survival curves. The impact of aspirin, statins,
metformin, angiotensin converting enzyme (ACE)-inhibitors and beta-blocking agents on the
risk of recurrence will be estimated using Cox regression models. Variables resulting
significant (p value <0.05) at univariate analysis or variables which are known
prognostic/risk factors will be included in the multivariable regression models. A p value of
<0.05 will be considered statistically significant. Statistical analysis will be conducted
using SPSS v23 (IBM, Armonk, New York, USA) and R v3.3.0 (https://cran.r-project.org).
