- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724435
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry (ARRAY)
ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sarah Lawrence
- Phone Number: 831 301-338-0912
- Email: NCR_PCA_Registry@navitaslifesciences.com
Study Locations
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Pleven, Bulgaria
- Medical University of Pleven
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Seoul, Korea, Republic of
- Seoul National University
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Taipei, Taiwan
- National Taiwan University Hospital
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Oxford
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Headington, Oxford, United Kingdom
- Oxford University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pancreatic Cancer Participants
No intervention will be administered.
Assessments are performed as standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Survival
Time Frame: 1 year
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Time until the occurence of death
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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) .
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Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
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Performance Status
Time Frame: Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
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Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.
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Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
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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
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The proportion of participants with a CBR will be measured at each follow-up time point.
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Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
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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
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Standardized instrument to measure of health-related quality of life.
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Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joo Ha Hwang, MD, PhD, Stanford University
- Principal Investigator: Joan Vidal-Jove, MD, PhD, Hospital Universitario Mutua Terrassa
- Study Director: Tim Meakem, MD, Focused Ultrasound Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUSREG001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
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Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
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University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
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Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina