Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05010226
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-18
First Post:
2021-07-27
Brief Title:
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the registry is to collect data on the performance of the focused ultrasound FUS technology and health outcomes A wide variety of approaches exist for using FUS on pancreatic cancer patients and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health This information will help provide a better understanding of current care and may possibly direct further more specific investigations that will follow this registry
Detailed Description:
This is a single-group multi-center observational log-in study Patients will be screened for clinically diagnosed pancreatic cancer and are scheduled to receive focused ultrasound therapy at National Taiwan University Hospital to determine their eligibility for participation After confirming that the patient has agreed the patient will be followed up for 12 months to observe safety tumor response changes in clinical manifestations and changes in the process of focused ultrasound treatment and quality of life after treatment The overall survival and disease progression time will be tracked within 3 days before and after the 7th day of focused ultrasound treatment to death or 12 months with the earlier occurrence being the priority The patients survival status will be tracked for 1 year
The physical condition will be evaluated by laboratory tests during the baseline screening the next day after treatment and 7 days 14 days 1 month 2 months 3 months 6 months and 12 months Including blood tests serum biochemical tests tumor indicators etc quality of life assessment including pain index score VAS and SF-36 life scale The MOS item short-form health survey SF-36 will be one after treatment Evaluation starts in the following month MRI imaging examination all examinations and treatments have been carried out in the 201701032DIPD clinical trial case This case is only an observational clinical trial case for data registration
The baseline screening before treatment will be carried out between the -3 days and the 0 days before the treatment The overall survival time OS will be tracked for 1 year the time to disease progression TTP and progression-free survival PFS will continue to be tracked during the trial until the patient dies or undergoes other curative procedures tracking should be carried out every 3 months once Concomitant drugstreatments and adverse events will be tracked continuously during the trial period
The physical condition will be evaluated by laboratory tests during the baseline screening the next day after treatment and 7 days 14 days 1 month 2 months 3 months 6 months and 12 months Including blood tests serum biochemical tests tumor indicators etc quality of life assessment including pain index score VAS and SF-36 life scale The MOS item short-form health survey SF-36 will be one after treatment Evaluation starts in the following month MRI imaging examination all examinations and treatments have been carried out in the 201701032DIPD clinical trial case This case is only an observational clinical trial case for data registration
The baseline screening before treatment will be carried out between the -3 days and the 0 days before the treatment The overall survival time OS will be tracked for 1 year the time to disease progression TTP and progression-free survival PFS will continue to be tracked during the trial until the patient dies or undergoes other curative procedures tracking should be carried out every 3 months once Concomitant drugstreatments and adverse events will be tracked continuously during the trial period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None