Study of Personalized Cancer Therapy to Determine Response and Toxicity

Cancer Clinical Trial

— UCSD_PREDICT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02478931
• Other study ID #: 130794
• Status: Recruiting
• Start date: September 5, 2013
• Est. completion date: September 5, 2026

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: Lee Suzanna, MPH
• Phone: (858) 534-1306
• Email: sml012[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 5, 2026
• Est. primary completion date: September 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Eisenhower Medical Center, Lucy Curci Cancer Center	Rancho Mirage	California
United States	Rady Children's Hospital, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Shu Mei Kato

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Tumor Biomarker Profiling to Treatment Outcome	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.	4 years
Secondary	Comparison of Tumor Biomarker Profiling to Toxicity Outcome	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.	4 years