Summary

Eligibility
for people ages 7 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Shumei Kato, MD
Headshot of Shumei Kato
Shumei Kato

Description

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.

Official Title

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

Details

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.

Keywords

Cancer

Eligibility

You can join if…

Open to people ages 7 years and up

  • Must be willing to provide informed consent, parent permission, or assent

You CAN'T join if...

  • Subjects unable to give informed consent, parent permission, or assent

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Rady Children's Hospital, San Diego accepting new patients
    San Diego California 92123 United States
  • Eisenhower Medical Center, Lucy Curci Cancer Center accepting new patients
    Rancho Mirage California 92270 United States

Lead Scientist at UCSD

  • Shumei Kato, MD
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 94 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shu Mei Kato
ID
NCT02478931
Study Type
Observational
Participants
Expecting 10000 study participants
Last Updated