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Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study

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Summary

This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.

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Full Description

PRIMARY OBJECTIVES:

I. The principal objective of the RESIN registry is to evaluate response to therapy using objective response criteria such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of the Liver (EASL). The response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. Secondary criteria include overall survival, time to progression (TTP) and toxicity.

OUTLINE:

Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall oncologic management are added in the RESIN registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients receiving SIR-Spheres therapy to the liver for the first time.
Provision of written informed consent.
Age 18 and older.

Exclusion Criteria:

Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres).

-Patients who have received Y90 treatment in the past and who are returning for another Y90 treatment are ineligible, even if new areas are being targeted.

Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.

Study is for people with:

Breast Cancer

Estimated Enrollment:

1653

Study ID:

NCT02685631

Recruitment Status:

Completed

Sponsor:

Vanderbilt-Ingram Cancer Center

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There are 5 Locations for this study

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University of Alabama
Birmingham Alabama, , United States
University of Arizona Health Sciences
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, , United States
Cedars-Sinai Medical Center
Los Angeles California, , United States
California Pacific Medical Center
San Francisco California, , United States
University of California, San Francisco
San Francisco California, , United States
Stanford University
Stanford California, , United States
University of Colorado, Denver
Denver Colorado, , United States
Sky Ridge Medical Center
Englewood Colorado, , United States
Christiana Care Health System
Wilmington Delaware, 19899, United States
Georgetown University
Washington District of Columbia, , United States
Baptist Hospital of Miami
Miami Florida, , United States
University of Miami
Miami Florida, , United States
Sarasota Memorial Hospital
Sarasota Florida, , United States
Tampa General Hospital
Tampa Florida, , United States
Cancer Treatment Centers of America
Atlanta Georgia, , United States
Emory University
Atlanta Georgia, , United States
Piedmont Hospital
Atlanta Georgia, , United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
University of Kansas Medical Center
Kansas City Kansas, , United States
Ochsner Clinic Foundation
New Orleans Louisiana, , United States
University of Maryland School of Medicine
Baltimore Maryland, , United States
Massachusetts General Hospital
Boston Massachusetts, , United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Saint Louis University
Saint Louis Missouri, , United States
Albany Medical Center
Albany New York, , United States
Roswell Park Cancer Institute
Buffalo New York, , United States
Northwell Health- Lenox Hill Hospital
New York New York, , United States
Carolinas Medical Center
Charlotte North Carolina, , United States
Wake Forest Medical Center
Winston-Salem North Carolina, , United States
Cleveland Clinic
Cleveland Ohio, , United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, , United States
Oregon Health & Science University
Portland Oregon, , United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, , United States
Penn State Health Saint Joseph Medical Center
Reading Pennsylvania, , United States
Spartanburg Regional Healthcare System
Spartanburg South Carolina, , United States
Sanford USD Medical Center
Sioux Falls South Dakota, , United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Methodist Health System
Dallas Texas, , United States
Houston Methodist Hospital
Houston Texas, , United States
The University of Utah
Salt Lake City Utah, , United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, , United States
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Study is for people with:

Breast Cancer

Estimated Enrollment:

1653

Study ID:

NCT02685631

Recruitment Status:

Completed

Sponsor:


Vanderbilt-Ingram Cancer Center

How clear is this clinincal trial information?

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