Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 2871 for:    Pancreatic Cancer

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 : 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

Tracking Information
First Submitted Date August 31, 2018
First Posted Date October 30, 2018
Last Update Posted Date July 30, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2018)
Survival [ Time Frame: 1 year ]
Time until the occurence of death
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03724435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 26, 2018)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 26, 2018)
  • Pain Related to Pancreatic Cancer [ Time Frame: Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter ]
    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 ]
    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 ]
    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 ]
    Standardized instrument to measure of health-related quality of life.
 
Descriptive Information
Brief Title 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
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

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples With DNA
Description:
Hematology, serum chemistry and tumor histology will be performed.
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.
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts Pancreatic Cancer Participants
No intervention will be administered. Assessments are performed as standard of care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 26, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2022
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tanisha Brown-Caines 301-770-2730 ext 1831 TCaines@kai-research.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03724435
Other Study ID Numbers FUSREG001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Focused Ultrasound Foundation
Study Sponsor Focused Ultrasound Foundation
Collaborators KAI Research
Investigators
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
PRS Account Focused Ultrasound Foundation
Verification Date July 2019