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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
Sponsor:
Collaborator:
KAI Research
Information provided by (Responsible Party):
Focused Ultrasound Foundation

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.

Condition or disease
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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Pancreatic Cancer Participants
No intervention will be administered. Assessments are performed as standard of care.



Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    Time until the occurence of death


Other Outcome Measures:
  1. 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) .

  2. 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.

  3. 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.

  4. 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
Hematology, serum chemistry and tumor histology will be performed.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Tanisha Brown-Caines 301-770-2730 ext 1831 TCaines@kai-research.com

Sponsors and Collaborators
Focused Ultrasound Foundation
KAI Research
Investigators
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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

Additional Information:

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Responsible Party: Focused Ultrasound Foundation
ClinicalTrials.gov Identifier: NCT03724435     History of Changes
Other Study ID Numbers: FUSREG001
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Focused Ultrasound Foundation:
pancreatic cancer
focused ultrasound
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases