Study of Personalized Cancer Therapy to Determine Response and Toxicity

Status:	Recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	7 - Any
Updated:	12/8/2018
Start Date:	September 2013
End Date:	September 2020
Contact:	Lee Suzanna, MPH
Email:	sml012@ucsd.edu
Phone:	(858) 534-1306

UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)

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.

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.

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

We found this trial at

sites

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California 92270

Principal Investigator: Henry Tsai, MD

Phone: 760-837-8034

from

Rancho Mirage, CA