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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01837 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC GI 1523 | Other Identifier | Vanderbilt University/Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational/data registry collection | Patients receiving Yttrium-90 resin microspheres as part of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 Resin Microspheres | Other | Data collection into the RESIN registry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease | Response to treatment is the initial measure of treatment efficacy. This can be measured using objective criteria such as the modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of Liver Cancer (EASL) criteria depending on local policy and tumor type. | Up to 1 year after the first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures | Overall toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures. Tracking this outcome can help define optimal combinations of Y90 plus systemic or biologic therapy to be used in formal research studies in the future |
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Inclusion Criteria:
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.
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Patients with primary and secondary liver cancer receiving SIR Spheres® microspheres (Y90 resin microspheres) treatment as part of their overall oncologic management
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Brown | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | United States | |||
| University of Arizona Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39009301 | Derived | Zhou W, Du L, Brown DB, Shah RP, Sze DY. Outcomes Analysis of Yttrium-90 Radioembolization for Tumors Other Than Metastatic Colorectal Cancer from the Radiation-Emitting SIR-Spheres in Nonresectable (RESiN) Registry. J Vasc Interv Radiol. 2024 Nov;35(11):1591-1600.e3. doi: 10.1016/j.jvir.2024.07.006. Epub 2024 Jul 14. | |
| 35762890 | Derived | Emmons EC, Bishay S, Du L, Krebs H, Gandhi RT, Collins ZS, O'Hara R, Akhter NM, Wang EA, Grilli C, Brower JS, Peck SR, Petroziello M, Abdel Aal AK, Golzarian J, Kennedy AS, Matsuoka L, Sze DY, Brown DB. Survival and Toxicities after 90Y Transarterial Radioembolization of Metastatic Colorectal Cancer in the RESIN Registry. Radiology. 2022 Oct;305(1):228-236. doi: 10.1148/radiol.220387. Epub 2022 Jun 28. |
| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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We plan on reporting group outcomes by tumor type or subtype. Individual records will be subject to HIPAA rules
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| Up to 1 year after the first treatment |
| Overall Survival | As noted above, overall survival is the optimal outcome measure with any oncologic therapy. However, the majority of patients will receive additional therapy after progressing on a given treatment regimen. For this reason, overall survival assessment with Y90 is a secondary, rather than a primary assessment endpoint in this registry study. | 2 years |
| Time to Progression | Overall survival is the definitive measure of any oncologic therapy. However, many if not all patients receive other treatments at the time of tumor progression. For this reason TTP may be the most accurate measure of oncologic efficacy following Y90 treatment. | 2 years |
| 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 D.C. | 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 | St 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 |
| 35232410 | Derived | Wong TY, Zhang KS, Gandhi RT, Collins ZS, O'Hara R, Wang EA, Vaheesan K, Matsuoka L, Sze DY, Kennedy AS, Brown DB. Long-term outcomes following 90Y Radioembolization of neuroendocrine liver metastases: evaluation of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry. BMC Cancer. 2022 Mar 1;22(1):224. doi: 10.1186/s12885-022-09302-z. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D018281 | Cholangiocarcinoma |
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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