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Competing trial will publish similar results
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| Name | Class |
|---|---|
| Navitas Clinical Research, Inc | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cancer Participants | No intervention will be administered. Assessments are performed as standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival | Time until the occurence of death | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Related to Pancreatic Cancer | 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) . | Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joo Ha Hwang, MD, PhD | Stanford University | Principal Investigator |
| Joan Vidal-Jove, MD, PhD | Hospital Universitario MĂștua Terrassa | Principal Investigator |
| Tim Meakem, MD | Focused Ultrasound Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Pleven | Pleven | Bulgaria | ||||
| Seoul National University |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Performance Status | Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening. | Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months |
| Clinical Benefit Response (CBR) | The proportion of participants with a CBR will be measured at each follow-up time point. | Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months |
| Impact on Quality of Life and Cost | Standardized instrument to measure of health-related quality of life. | Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months |
| Seoul |
| South Korea |
| National Taiwan University Hospital | Taipei | Taiwan |
| Oxford University Hospital | Headington | Oxford | United Kingdom |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |