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Trial record 2 of 9 for:    focused ultrasound | pancreatic cancer

Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry

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ClinicalTrials.gov Identifier: NCT05010226
Recruitment Status : Not yet recruiting
First Posted : August 18, 2021
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date July 27, 2021
First Posted Date August 18, 2021
Last Update Posted Date August 18, 2021
Estimated Study Start Date September 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 10, 2021)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 10, 2021)
Impact on Quality of Life and Cost [ Time Frame: over 12 months ]
Standardized instrument to measure of health-related quality of life.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
Official Title Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
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 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • Pancreatic Cancer
  • Focused Ultrasound
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 10, 2021)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2026
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • In order to be eligible to participate in this registry, an individual must meet all of the following criteria:

    1. 20 years and older
    2. Provision of signed and dated informed consent form
    3. Stated willingness to comply with all registry procedures and availability for the duration of the registry
    4. Histology proven pancreatic carcinoma in any area of pancreas
    5. Pancreatic tumor that can be treated by FUS
    6. Willingness and ability to complete follow-up interviews
    7. Patients have agreed to participate in the clinical trial 201701032DIPD and were scheduled to receive FUS therapy in our hospital

Exclusion Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this registry:

    1. Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
    2. Clinical trials of pancreatic cancer not of focused ultrasound or related activities
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kai-Wen Huang, M.D. Ph.D 886-2-23123456 ext 66144 skywing@ntuh.gov.tw
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05010226
Other Study ID Numbers 202007081RINB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Kai-Wen Huang, M.D. Ph.D National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date July 2021