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NCT02478931Recruiting

Study of Personalized Cancer Therapy to Determine Response and Toxicity

Shu Mei Kato

Start Date

9/5/2013

Completion Date

9/5/2027

Summary

The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information about the tests and treatments a person received, or will receive, for their cancer will be collected from medical records to help the researchers determine whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor. Optional research tests may be performed on tissue, body cavity fluid, blood or urine provided, discarded biological samples taken during routine care that would normally be disposed of and not saved, or on blood samples collected for this study. These research tests will be used to create a "profile" of the collected specimens which will describe unique characteristics about the genes involved in a person's cancer. The tests will also help researchers look for biomarkers that may help predict how people respond to treatment.

Detailed Description

This is a correlative study of personalized medicine with retrospective and prospective components. Patient medical records will be examined for results of molecular profiling obtained through standard of care testing to help understand, in a descriptive fashion, how well molecular testing might predict response to therapy. Patient outcome parameters including, but not limited to, tumor response, time to treatment failure, patient survival, and toxicity will be analyzed, as well as pharmacodynamic (PD) and pharmacokinetic (PK) data when available. This study will also include optional research-related testing of tissue, blood, or urine specimens via a variety of simple or advanced techniques such as molecular, proteomic, and metabolic analyses for biomarker discovery or for PK and PD parameters. These specimens will be obtained from clinical specimens archived by UCSD Health System Pathology or from specimens collected via an existing IRB-approved protocol, discarded specimens, or from specimens collected for this protocol.

Eligibility Criteria

Age Range: 7 years to No maximum

Inclusion Criteria: * Must be willing to provide informed consent, parent permission, or assent Exclusion Criteria: * Subjects unable to give informed consent, parent permission, or assent

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Conditions

Cancer

Locations

UCSD Moores Cancer Center

La Jolla, California 92093

United States

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California 92270

United States

Rady Children's Hospital, San Diego

San Diego, California 92123

United States