Pancreatic CancerNCT05010226
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
An observational study of Pancreatic Cancer and Focused Ultrasound, run by National Taiwan University Hospital.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Cancer, Focused Ultrasound
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry will be implemented at approximately 10 sites internationally. In order to achieve the target registry population of 30 participants over 12 months in the NTUH site, participants who receive focused ultrasound for pancreatic cancer. Participant enrollment will be evaluated on a site by site basis throughout the enrollment period to provide diversity of participant and system representation.
Who may be able to join
- In order to be eligible to participate in this registry, an individual must meet all of the following criteria:
- 20 years and older
- Provision of signed and dated informed consent form
- Stated willingness to comply with all registry procedures and availability for the duration of the registry
- Histology proven pancreatic carcinoma in any area of pancreas
- Pancreatic tumor that can be treated by FUS
- Willingness and ability to complete follow-up interviews
- Patients have agreed to participate in the clinical trial 201701032DIPD and were scheduled to receive FUS therapy in our hospital
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this registry:
- Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
- Clinical trials of pancreatic cancer not of focused ultrasound or related activities
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 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.
- Conditions
- Pancreatic Cancer, Focused Ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain related to pancreatic cancer
Brief Pain Inventory from 0 (no pain) to 10 (pain as a bad as can imagine)
Measured: after high focused ultrasound treatment, an average of 1 month
To observe the efficacy of local tumor ablation
the assessment of the tumor burden after high focused ultrasound treatment
Measured: after high focused ultrasound treatment, an average of 1 month
The effect of local tumor ablation
time-to-progression
Measured: over 12 months
To observe the survival rate
overall survival (OS)
Measured: over 12 months
To observe the progression-free survival rate
observation of the progression-free survival
Measured: over 12 months
To evaluate clinical benefit response (CBR)
The proportion of participants with a CBR will be measured at each follow-up time point
Measured: over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, M.D. Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010226
- Sponsor's protocol ID
- 202007081RINB
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
- ClinicalTrials.gov ID
- NCT05010226
- Acronym / sponsor ID
- 202007081RINB
- Conditions
- Pancreatic Cancer, Focused Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Aug 2021 (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 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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will be implemented at approximately 10 sites internationally. In order to achieve the target registry population of 30 participants over 12 months in the NTUH site, participants who receive focused ultrasound for pancreatic cancer. Participant enrollment will be evaluated on a site by site basis throughout the enrollment period to provide diversity of participant and system representation.
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this registry, an individual must meet all of the following criteria:
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this registry:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain related to pancreatic cancer
Time frame: after high focused ultrasound treatment, an average of 1 month
Brief Pain Inventory from 0 (no pain) to 10 (pain as a bad as can imagine)
To observe the efficacy of local tumor ablation
Time frame: after high focused ultrasound treatment, an average of 1 month
the assessment of the tumor burden after high focused ultrasound treatment
The effect of local tumor ablation
Time frame: over 12 months
time-to-progression
To observe the survival rate
Time frame: over 12 months
overall survival (OS)
To observe the progression-free survival rate
Time frame: over 12 months
observation of the progression-free survival
To evaluate clinical benefit response (CBR)
Time frame: over 12 months
The proportion of participants with a CBR will be measured at each follow-up time point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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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.
Kai-Wen Huang, M.D. Ph.D principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Focused Ultrasound, run by National Taiwan University Hospital.
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 3 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kai-Wen Huang, M.D. Ph.D (886-2-23123456 ext. 66144, skywing@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related to pancreatic cancer (time frame: after high focused ultrasound treatment, an average of 1 month). The study lists 6 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 18 Aug 2021.