Pancreatic CancerARRAYNCT03724435
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
An observational study of Pancreatic Cancer, run by Focused Ultrasound Foundation at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 21 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 6 Dec 2019to 30 Nov 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
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.
Read the 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
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, focused ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer Participants | No intervention will be administered. Assessments are performed as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Time until the occurence of death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start6 Dec 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Competing trial will publish similar results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Focused Ultrasound Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Navitas Clinical Research, Inc
- Responsible party
- Sponsor
- Investigators
- Joo Ha Hwang, MD, PhD, Principal investigator, Stanford UniversityJoan Vidal-Jove, MD, PhD, Principal investigator, Hospital Universitario Mútua TerrassaTim Meakem, MD, Study director, Focused Ultrasound Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724435
- Sponsor's protocol ID
- FUSREG001
- Acronym
- ARRAY
- Status last verified
- Mar 2024
- First submitted
- 31 Aug 2018
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
- ClinicalTrials.gov ID
- NCT03724435
- Acronym / sponsor ID
- ARRAY / FUSREG001
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, focused ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Competing trial will publish similar results
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Focused Ultrasound FoundationUniversity, hospital or other
- Collaborators
- Navitas Clinical Research, Inc
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer Participants | – | –No intervention will be administered. Assessments are performed as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 1 year
Time until the occurence of death
Results and safety
The study was stopped early (reason given: Competing trial will publish similar results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Ha Hwang, MD, PhD principal investigator
Stanford University
Joan Vidal-Jove, MD, PhD principal investigator
Hospital Universitario Mútua Terrassa
Tim Meakem, MD study director
Focused Ultrasound Foundation
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Focused Ultrasound Foundation at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bulgaria, South Korea, Taiwan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Competing trial will publish similar results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.