Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, focused ultrasound
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
Interventions
None listed
Sponsors
Navitas Clinical Research, Inc
Focused Ultrasound Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1 year | Time until the occurence of death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Performance Status | 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) | 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. |
| Pain Related to Pancreatic Cancer | 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) . |
| Impact on Quality of Life and Cost | 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. |
Countries
Bulgaria, South Korea, Taiwan, United Kingdom
Outcome results
None listed