Disease Free SurvivalCAOSNCT04245644
Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study
An observational study of Disease Free Survival and Overall Survival, run by Massimo Falconi at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease Free Survival, Overall Survival, Pancreatic Cancer
- What is being tested?
- use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, Statins
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2019to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population with a diagnosis of pancreatic ductal adenocarcinoma in any portion of the glande, with or without metastases in other sites
Who may be able to join
- 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
Who cannot join
- age under 18 years
- lack of cytological or histological diagnosis of pancreatic ductal adenocarcinoma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 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 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.
Read the detailed 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).
- Conditions
- Disease Free Survival, Overall Survival, Pancreatic Cancer
- Being tested
- use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, Statins
- Keywords
- aspirin,, metformin, statin, ACE-inhibitors, beta-blockers, pancreatic cancer, survival
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, StatinsBehavioural
enrolled patients will be asked details regarding their daily drug use, before and after diagnosis of pancreatic cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
probability of recurrence or progression of disease in patients on regular treatment with targeted drugs compared with non-users
Measured: two-years follow-up
Overall survival
risk of death for disease in patients on regular treatment with targeted drugs compared with non-users
Measured: two-years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start2 Mar 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Free SurvivalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Massimo Falconi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Massimo Falconi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245644
- Sponsor's protocol ID
- CAOS
- Acronym
- CAOS
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chemopreventive Agents on Disease-free and Overall Survival in Patients With Pancreatic Ductal Adenocarcinoma: The CAOS Study
- ClinicalTrials.gov ID
- NCT04245644
- Acronym / sponsor ID
- CAOS / CAOS
- Conditions
- Disease Free Survival, Overall Survival, Pancreatic Cancer
- Keywords
- aspirin,, metformin, statin, ACE-inhibitors, beta-blockers, pancreatic cancer, survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Massimo FalconiUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- cytological or histological diagnosis of pancreatic ductal adenocarcinoma in any portion of the gland, 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 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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with a diagnosis of pancreatic ductal adenocarcinoma in any portion of the glande, with or without metastases in other sites
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age under 18 years
- lack of cytological or histological diagnosis of pancreatic ductal adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, Statinsenrolled patients will be asked details regarding their daily drug use, before and after diagnosis of pancreatic cancer | Behavioural | – |
Primary outcome
Disease free survival
Time frame: two-years follow-up
probability of recurrence or progression of disease in patients on regular treatment with targeted drugs compared with non-users
Overall survival
Time frame: two-years follow-up
risk of death for disease in patients on regular treatment with targeted drugs compared with non-users
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Disease Free Survival
RecruitingObservational study
Long-term Follow-up of Subjects Treated With CAR T Cells
Long Term Adverse Effects, CAR-T
Not yet recruitingPhase 3
A Non-inferiority Study of Indocyanine Green-guided Sentinel Lymph Node Mapping Versus Conventional Lymph Node Dissection in Esophageal Cancer
Esophageal Cancer, Sentinel Lymph Node
RecruitingPhase 2
Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies
Disease-free Survival
Enrolling by invitationObservational study
Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.
Colorectal Cancer, Early Onset Colorectal Cancer
Active, not recruitingPhase 4
A Clinical Trial of STAtin Therapy for Reducing Events in the Elderly (STAREE)
Independent Living, Disability Free Survival
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease Free Survival and Overall Survival, run by Massimo Falconi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: two-years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.