Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry (ARRAY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03724435|
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : June 29, 2022
|Condition or disease|
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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY|
|Actual Study Start Date :||December 6, 2019|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||June 30, 2025|
Pancreatic Cancer Participants
No intervention will be administered. Assessments are performed as standard of care.
- Survival [ Time Frame: 1 year ]Time until the occurence of death
- Pain Related to Pancreatic Cancer [ Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]The proportion achieving a 2 point reduction or greater will be assessed at each time point and across time using the Brief Pain Inventory (Short Form). Pain will be rated from 0 (no pain) to 10 (pain as a bad as can imagine) .
- Performance Status [ Time Frame: Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.
- Clinical Benefit Response (CBR) [ Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]The proportion of participants with a CBR will be measured at each follow-up time point.
- Impact on Quality of Life and Cost [ Time Frame: Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months ]Standardized instrument to measure of health-related quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724435
|Contact: Sarah Lawrence||301-338-0912 ext 831||NCR_PCA_Registry@navitaslifesciences.com|
|Medical University of Pleven||Recruiting|
|Contact: Dobromir Dimitrov firstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Jae-Young Lee email@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Kai-Wen Huang firstname.lastname@example.org|
|Oxford University Hospital||Recruiting|
|Headington, Oxford, United Kingdom|
|Contact: Srikanth Reddy, FRCS, PhD Srikanth.Reddy@ouh.nhs.uk|
|Principal Investigator:||Joo Ha Hwang, MD, PhD||Stanford University|
|Principal Investigator:||Joan Vidal-Jove, MD, PhD||Hospital Universitario Mútua Terrassa|
|Study Director:||Tim Meakem, MD||Focused Ultrasound Foundation|