Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study
-
- STATUS
- Recruiting
-
- participants needed
- 800
-
- sponsor
- Massimo Falconi
Summary
The evidence on the value of
The aim of this study is to assess whether regular use of
400 patients with the following inclusion criteria will be enrolled in 3 years:
- cytological or histological diagnosis of
pancreatic ductal adenocarcinoma in any portion of the gland, with or withoutmetastases in other sites - patient age between 18 and 90 years
- any medicine or drug in the daily patient
therapy - Patients undergone to primary
chemoradiotherapy orsurgical resection , followed byadjuvant therapy or preceded by neoadjuvantchemoradiotherapy , are included in the study Anamnestic, clinical and pathological data, included data on theaspirin , 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
Inclusion and exclusion criteria
Inclusion criteria are:
- cytological or histological diagnosis of
pancreatic ductal adenocarcinoma in any portion of the gland, with or withoutmetastases in other sites - patient age between 18 and 90 years
- any medicine or drug in the daily patient
therapy - Patients undergone to primary
chemoradiotherapy orsurgical resection , followed byadjuvant therapy or preceded by neoadjuvantchemoradiotherapy , are included in the study
Exclusion criteria are:
- age under 18 years
- lack of cytological or histological diagnosis of
pancreatic ductal adenocarcinoma
Data collection methods
Anamnestic, clinical and pathological data, included data on the
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
Details
Condition |
Pancreatic |
---|---|
Age | 18years - 100years |
Treatment |
use of targeted drugs such as |
Clinical Study Identifier | NCT04245644 |
Sponsor | Massimo Falconi |
Last Modified on | 19 February 2024 |
How to participate?
,
Select a site
Enter your location to find study centers near you
study centers available
Send a message
Enter your contact details to connect with study team
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Enable the functional cookies in order to view/reply the sharedadd your annotations.
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Publish Annotation
Are you sure you want to publish the annotation?
Delete AnnotationNote
Are you sure you want to delete the annotationnote?
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.