Study of Personalized Cancer Therapy to Determine Response and Toxicity

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.

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Key information

Conditions

Cancer Neoplasms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSD Moores Cancer Center, La Jolla, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Comparison of Tumor Biomarker Profiling to Treatment Outcome

Time frame: 4 years

Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)>6months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Logistic regression models (univariable and multivariables) will be used when the outcome variable is dichotomous. Kaplan-meier curves will be used for time-to event outcomes, and comparisons will be done with the log-rank test and Cox regression models.

Secondary outcomes

Comparison of Tumor Biomarker Profiling to Toxicity Outcome

Time frame: 4 years

Tumor molecular profiles will be correlated to toxicity rate (serious toxic effects, primarily Grade 3 to 5 toxicity), but may also include less serious chronic toxicity. Toxicity will be assessed using NCI CTCAE, version 4.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Suzanna, MPH

CONTACT

[email protected]

(858) 534-1306

Michaela Doering, BS

CONTACT

[email protected]

(858) 657-7512

Sponsors and collaborators

Lead sponsor

Shu Mei Kato

Other

Registry information

Official study title

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

Acronym: UCSD_PREDICT

Important dates

Study start: 2013
Primary completion: 2026
Study completion: 2027
First posted: Jun 23, 2015
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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