Clinical trial NCT03724435: Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
Official title: ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
focused ultrasound
Lead sponsor: Focused Ultrasound Foundation
Sponsor class: OTHER
Collaborators: name: Navitas Clinical Research, Inc
First posted: 2018-10-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry population will be drawn from patients who have been diagnosed with pancreatic cancer and are eligible for FUS therapy. Participants are allowed to receive standard-of-care treatment, including chemotherapy, radiation therapy, and best supportive care. Participants being treated in another FUS clinical trial may be included in this registry.

Brief summary: This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.

Detailed description: 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. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions.

Enrollment Goal: 100

Primary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Other non-pancreatic cancer clinical trials

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Pain Related to Pancreatic Cancer
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
measure: Performance Status
timeFrame: Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
measure: Clinical Benefit Response (CBR)
timeFrame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
measure: Impact on Quality of Life and Cost
timeFrame: Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Locations:
city: Pleven
country: Bulgaria
facility: Medical University of Pleven
city: Seoul
country: Korea, Republic of
facility: Seoul National University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Headington
country: United Kingdom
facility: Oxford University Hospital
state: Oxford
Study officials:
affiliation: Stanford University
name: Joo Ha Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Mútua Terrassa
name: Joan Vidal-Jove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Focused Ultrasound Foundation
name: Tim Meakem, MD
role: STUDY_DIRECTOR
References: