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

NCT05010226 | Not Yet Recruiting

• 1 other identifier: 202007081RINB
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer; Focused Ultrasound

Outcome Measures

Primary Outcomes (6)

• Pain related to pancreatic cancer

  Brief Pain Inventory from 0 (no pain) to 10 (pain as a bad as can imagine)

  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

  after high focused ultrasound treatment, an average of 1 month

• The effect of local tumor ablation

  time-to-progression

  over 12 months

• To observe the survival rate

  overall survival (OS)

  over 12 months

• To observe the progression-free survival rate

  observation of the progression-free survival

  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

  over 12 months

Other Outcomes (1)

• Impact on Quality of Life and Cost

  over 12 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Kai-Wen Huang, M.D. Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai-Wen Huang, M.D. Ph.D

CONTACT

886-2-23123456; skywing@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 18, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 18, 2021

Record last verified: 2021-07