Metastatic Pancreatic CancerNCT06106568
An Observational Study to Learn More About the Impact of Gadoxetate Sodium-Enhanced Magnetic Resonance Imaging (EOB-MRI) When Used to Diagnose the Spread of Cancer From the Pancreas to the Liver in Japanese People Under Real-World Conditions
An observational study of Metastatic Pancreatic Cancer and Liver Metastases, run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, Liver Metastases, Gadoxetate Sodium-enhanced Magnetic Resonance Imaging
- What is being tested?
- EOB-MRI, Surgery and Open-close Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 39,624 participants
- Where
- 1 siteJapan
- Study dates
- 20 Nov 2023to 30 Oct 2024
- 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: This is a retrospective observational study utilizing data extracted from a hospital-based administrative health insurance claims database provided by Medical Data Vision Co. Ltd (MDV, Tokyo, Japan). Eligible patients are adult patients with a confirmed diagnosis of pancreatic cancer (identified by International Classification of Diseases, 10th revision [ICD-10] code C25.x) during the overall study period (i.e., between 01 Jan 2011 and 31 Oct 2022) .
Who may be able to join
- Patients having at least one confirmed diagnosis of pancreatic cancer (identified by ICD-10 diagnosis code C25.x, without a suspicious diagnosis flag) during the patient selection period
- Patients having at least one active treatment record after the 1st confirmed diagnosis of pancreatic cancer
- Patients 18 years of age or older at the index date
- Patients having any recorded CE-CT or EOB-MRI or MRI without EOB record during the baseline period
- EOB-MRI stands for enhanced liver MRI using gadoxetate sodium as the contrast agent. In this type of MRI, gadoxetate sodium is used as a contrast agent in the visualization of the liver tumor.
- EOB-MRI group will include patients who underwent EOB-MRI during the baseline period.
- Non-EOB-MRI group will include patients who underwent CE-CT or MRI with contrast agent other than the gadoxetate sodium during the baseline period.
- MRI, CE-CT and contrast agents are identified by using the nine-digit Japanese receipt code specified in the separate code list
Who cannot join
- Patients with no confirmed diagnosis of pancreatic cancer (ICD-10 diagnosis code C25.x) in the below category of the disease name in the discharge summary until the 1st discharge date after the index date:
- "ICD-10 code of disease name which input the most medical resources"
- "ICD-10 name of disease behind hospitalization"
- Patients with no active treatment within 3 months (90 days) from the con-firmed pancreatic cancer diagnosis date
- Patients with no medical record in the MDV database within 1 month (30 days) from the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study to Investigate the Clinical Impact of EOB-MRI in the Diagnosis of Liver Metastasis of Pancreatic Cancer in Japan - A Real-World Study
This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer.
Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver.
Read more
Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results.
Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions.
The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs.
The main information that researchers will collect in this study:
participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy
the length of time:
from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival)
from the date of first treatment for pancreatic cancer until the cancer spreads of other organs
from the date of diagnosis of pancreatic cancer to starting the first treatment
from the date of first treatment for pancreatic cancer to starting the second treatment option
treatments that the participants have received, including anti-cancer drugs, radiation, and surgery
the number of hospital visits, use of healthcare facilities, and related costs.
The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI.
The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022.
Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study.
In this study, only available data from health records are collected. No visits or tests are required as part of this study.
- Conditions
- Metastatic Pancreatic Cancer, Liver Metastases, Gadoxetate Sodium-enhanced Magnetic Resonance Imaging
- Being tested
- EOB-MRI, Surgery, Open-close Laparotomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOB-MRIProcedure or surgery
Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan
SurgeryProcedure or surgery
Retrospective analysis for pancreatic cancer patients who had a record of any surgery for the pancreatic cancer in the Medical Data Vision (MDV) database in Japan
Open-close LaparotomyProcedure or surgery
Retrospective analysis for pancreatic cancer patients who had a record of an open-close laparotomy in the Medical Data Vision (MDV) database in Japan
| Study group | Role | What they receive |
|---|---|---|
| EOB-MRI | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI Receives: Procedure: EOB-MRI | |
| non-EOB-MRI | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MBI | |
| EOB-MRI with surgery | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and surgery Receives: Procedure: EOB-MRI; Procedure: Surgery | |
| non-EOB-MRI with surgery | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of surgery Receives: Procedure: Surgery | |
| EOB-MRI without surgery | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI but without a record of surgery Receives: Procedure: EOB-MRI | |
| non-EOB-MRI without surgery | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI or surgery | |
| EOB-MRI with an open-close laparotomy | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and an open-close laparotomy Receives: Procedure: EOB-MRI; Procedure: Open-close Laparotomy | |
| non-EOB-MRI with an open-close laparotomy | Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of an open-close laparotomy Receives: Procedure: Open-close Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group
Measured: Up to 12 years
Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI group
Measured: Up to 12 years
Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI group
Measured: Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group
Measured: Up to 12 years
Secondary outcomes (14)
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Subgroups:
- with a record of surgery
- without a record of surgery
- with a record of an open-close laparotomy
Measured: Up to 12 years
Descriptive summary of clinical outcomes in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Subgroups:
- with a record of surgery
- without a record of surgery
- with a record of an open-close laparotomy
Measured: Up to 12 years
Descriptive summary of healthcare utilization pattern in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Subgroups:
- with a record of surgery
- without a record of surgery
- with a record of an open-close laparotomy
Measured: Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Subgroups:
- with a record of surgery
- without a record of surgery
- with a record of an open-close laparotomy
Measured: Up to 12 years
Comparison of overall survival (time from pancreatic cancer diagnosis date to death) (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Measured: Up to 12 years
Comparison of time to diagnosis of new metastases from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Measured: Up to 12 years
Comparison of time to first treatment pathway option from the pancreatic cancer diagnosis date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Measured: Up to 12 years
Comparison of time to second treatment pathway option from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Measured: Up to 12 years
Descriptive summary of patient characteristics across three index-year groups
The study period will be divided into index year groups defined as below:
- Group 1: 2011-2012
- Group 2: 2013-2018
- Group 3: 2019-2021
Measured: Up to 12 years
Descriptive summary of clinical outcomes across three index-year groups
The study period will be divided into index year groups defined as below:
- Group 1: 2011-2012
- Group 2: 2013-2018
- Group 3: 2019-2021
Measured: Up to 12 years
Descriptive summary of treatment pathways across three index-year groups
The study period will be divided into index year groups defined as below:
- Group 1: 2011-2012
- Group 2: 2013-2018
- Group 3: 2019-2021
Measured: Up to 12 years
Descriptive summary of healthcare utilization pattern across three index-year groups
The study period will be divided into index year groups defined as below:
- Group 1: 2011-2012
- Group 2: 2013-2018
- Group 3: 2019-2021
Measured: Up to 12 years
Descriptive summary of healthcare costs across three index-year groups
The study period will be divided into index year groups defined as below:
- Group 1: 2011-2012
- Group 2: 2013-2018
- Group 3: 2019-2021
Measured: Up to 12 years
Descriptive summary of the likelihood of open-close laparotomy in patients with confirmed diagnosis of pancreatic cancer who is intended the surgical intervention between those in the EOB-MRI group and non-EOB-MRI group
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start20 Nov 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 39,624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106568
- Sponsor's protocol ID
- 22470
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study to Investigate the Clinical Impact of EOB-MRI in the Diagnosis of Liver Metastasis of Pancreatic Cancer in Japan - A Real-World Study
- ClinicalTrials.gov ID
- NCT06106568
- Acronym / sponsor ID
- 22470
- Conditions
- Metastatic Pancreatic Cancer, Liver Metastases, Gadoxetate Sodium-enhanced Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,624 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 30 Oct 2023 (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.
This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer.
Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver.
Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results.
Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions.
The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs.
The main information that researchers will collect in this study:
participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy
the length of time:
from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival)
from the date of first treatment for pancreatic cancer until the cancer spreads of other organs
from the date of diagnosis of pancreatic cancer to starting the first treatment
from the date of first treatment for pancreatic cancer to starting the second treatment option
treatments that the participants have received, including anti-cancer drugs, radiation, and surgery
the number of hospital visits, use of healthcare facilities, and related costs.
The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI.
The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022.
Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study.
In this study, only available data from health records are collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| EOB-MRI | – | Procedure: EOB-MRIAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI |
| non-EOB-MRI | – | –Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MBI |
| EOB-MRI with surgery | – | Procedure: EOB-MRI, Procedure: SurgeryAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and surgery |
| non-EOB-MRI with surgery | – | Procedure: SurgeryAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of surgery |
| EOB-MRI without surgery | – | Procedure: EOB-MRIAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI but without a record of surgery |
| non-EOB-MRI without surgery | – | –Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI or surgery |
| EOB-MRI with an open-close laparotomy | – | Procedure: EOB-MRI, Procedure: Open-close LaparotomyAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and an open-close laparotomy |
| non-EOB-MRI with an open-close laparotomy | – | Procedure: Open-close LaparotomyAdult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of an open-close laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective observational study utilizing data extracted from a hospital-based administrative health insurance claims database provided by Medical Data Vision Co. Ltd (MDV, Tokyo, Japan). Eligible patients are adult patients with a confirmed diagnosis of pancreatic cancer (identified by International Classification of Diseases, 10th revision [ICD-10] code C25.x) during the overall study period (i.e., between 01 Jan 2011 and 31 Oct 2022) .
Key inclusion criteria (8 listed)
- Patients having at least one confirmed diagnosis of pancreatic cancer (identified by ICD-10 diagnosis code C25.x, without a suspicious diagnosis flag) during the patient selection period
- Patients having at least one active treatment record after the 1st confirmed diagnosis of pancreatic cancer
- Patients 18 years of age or older at the index date
- Patients having any recorded CE-CT or EOB-MRI or MRI without EOB record during the baseline period
Key exclusion criteria (5 listed)
- Patients with no confirmed diagnosis of pancreatic cancer (ICD-10 diagnosis code C25.x) in the below category of the disease name in the discharge summary until the 1st discharge date after the index date:
- Patients with no active treatment within 3 months (90 days) from the con-firmed pancreatic cancer diagnosis date
- Patients with no medical record in the MDV database within 1 month (30 days) from the index date
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 |
|---|---|---|
| EOB-MRIRetrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan | Procedure or surgery | EOB-MRI, EOB-MRI with an open-close laparotomy, EOB-MRI with surgery, EOB-MRI without surgery |
| SurgeryRetrospective analysis for pancreatic cancer patients who had a record of any surgery for the pancreatic cancer in the Medical Data Vision (MDV) database in Japan | Procedure or surgery | EOB-MRI with surgery, non-EOB-MRI with surgery |
| Open-close LaparotomyRetrospective analysis for pancreatic cancer patients who had a record of an open-close laparotomy in the Medical Data Vision (MDV) database in Japan | Procedure or surgery | EOB-MRI with an open-close laparotomy, non-EOB-MRI with an open-close laparotomy |
Primary outcome
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group
Time frame: Up to 12 years
Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI group
Time frame: Up to 12 years
Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI group
Time frame: Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group
Time frame: Up to 12 years
14 secondary outcomes
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Time frame: Up to 12 years
Descriptive summary of clinical outcomes in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Time frame: Up to 12 years
Descriptive summary of healthcare utilization pattern in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Time frame: Up to 12 years
Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group within the subgroups of interest
Time frame: Up to 12 years
Comparison of overall survival (time from pancreatic cancer diagnosis date to death) (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Time frame: Up to 12 years
Comparison of time to diagnosis of new metastases from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Time frame: Up to 12 years
Comparison of time to first treatment pathway option from the pancreatic cancer diagnosis date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Time frame: Up to 12 years
Comparison of time to second treatment pathway option from the index date (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)
Time frame: Up to 12 years
Descriptive summary of patient characteristics across three index-year groups
Time frame: Up to 12 years
Descriptive summary of clinical outcomes across three index-year groups
Time frame: Up to 12 years
Descriptive summary of treatment pathways across three index-year groups
Time frame: Up to 12 years
Descriptive summary of healthcare utilization pattern across three index-year groups
Time frame: Up to 12 years
Descriptive summary of healthcare costs across three index-year groups
Time frame: Up to 12 years
Descriptive summary of the likelihood of open-close laparotomy in patients with confirmed diagnosis of pancreatic cancer who is intended the surgical intervention between those in the EOB-MRI group and non-EOB-MRI group
Time frame: Up to 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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 Metastatic Pancreatic Cancer and Liver Metastases, run by Bayer at 1 site in Japan.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group (time frame: Up to 12 years). The study lists 4 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 4 Nov 2024.