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

NCT04245644 | Active Not Recruiting

• 1 other identifier: CAOS
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 1.cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the gland, with or without metastases in other sites
2. 2.patient age between 18 and 90 years
3. 3.any medicine or drug in the daily patient therapy
4. 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.

Conditions

Disease Free Survival; Overall Survival; Pancreatic Cancer

Keywords

aspirin,; metformin; statin; ACE-inhibitors; beta-blockers; pancreatic cancer; survival

Outcome Measures

Primary Outcomes (2)

• Disease free survival

  probability of recurrence or progression of disease in patients on regular treatment with targeted drugs compared with non-users

  two-years follow-up

• Overall survival

  risk of death for disease in patients on regular treatment with targeted drugs compared with non-users

  two-years follow-up

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult population with a diagnosis of pancreatic ductal adenocarcinoma in any portion of the glande, with or without metastases in other sites

You may qualify if:

• cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the glande, with or without metastases in other sites
• patient age between 18 and 90 years
• any medicine or drug in the daily patient therapy
• Patients undergone to primary chemoradiotherapy or surgical resection, followed by adjuvant therapy or preceded by neoadjuvant chemoradiotherapy, are included in the study

You may not qualify if:

• age under 18 years
• lack of cytological or histological diagnosis of pancreatic ductal adenocarcinoma

Sponsors & Collaborators

• Massimo Falconi: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Aspirin; Metformin; Angiotensin-Converting Enzyme Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Biguanides; Guanidines; Amidines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: March 2, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)