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2023-11-20
2024-10-30
2024-10-30
39624
NCT06106568
Bayer
Bayer
OBSERVATIONAL
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
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-24 | N/A | 2024-10-31 |
2023-10-24 | N/A | 2024-11-04 |
2023-10-30 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 | PROCEDURE: EOB-MRI
PROCEDURE: Surgery
PROCEDURE: Open-close Laparotomy
|
| : 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 | PROCEDURE: Surgery
PROCEDURE: Open-close Laparotomy
|
| : 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 | 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 | 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 | 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 | 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 | PROCEDURE: Open-close Laparotomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group | Up to 12 years | |
| Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI group | Up to 12 years | |
| Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI group | Up to 12 years | |
| Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group | Up to 12 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | Up to 12 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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