Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry (ARRAY)
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|ClinicalTrials.gov Identifier: NCT03724435|
Recruitment Status : Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : July 30, 2019
|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|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||January 31, 2022|
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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724435
|Contact: Tanisha Brown-Caines||301-770-2730 ext 1831||TCaines@kai-research.com|
|Principal Investigator:||Joo Ha Hwang, MD, PhD||Stanford University|
|Principal Investigator:||Franco Orsi, MD||Istituto Europeo di Oncologia|
|Study Director:||Tim Meakem, MD||Focused Ultrasound Foundation|