Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05010226 |
Other study ID # |
202007081RINB |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 2021 |
Est. completion date |
September 2026 |
Study information
Verified date |
July 2021 |
Source |
National Taiwan University Hospital |
Contact |
Kai-Wen Huang, M.D. Ph.D |
Phone |
886-2-23123456 |
Email |
skywing[@]ntuh.gov.tw |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 patient's 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 drugs/treatments and
adverse events will be tracked continuously during the trial period.