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Study of Personalized Cancer Therapy to Determine Response and Toxicity (UCSD_PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02478931
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : April 5, 2021
Information provided by (Responsible Party):
Shu Mei Kato, University of California, San Diego

Brief 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.

Condition or disease

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)
Actual Study Start Date : September 5, 2013
Estimated Primary Completion Date : September 5, 2025
Estimated Study Completion Date : September 5, 2026

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
Blood, urine, tissue, ascites, stool, tracheal aspirate, and cerebral spinal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a diagnosis of cancer or a cancer-related condition

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02478931

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Contact: Lee Suzanna, MPH (858) 534-1306
Contact: Michaela Doering, BS (858) 657-7512

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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Suzanna Lee    858-534-1306   
Eisenhower Medical Center, Lucy Curci Cancer Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Stephanie W Farrell, MBA    760-837-8034   
Principal Investigator: Henry Tsai, MD         
Rady Children's Hospital, San Diego Recruiting
San Diego, California, United States, 92123
Contact: Neera Gundrania, MPH    858-966-8823   
Principal Investigator: Dennis Kuo, MD         
Sponsors and Collaborators
Shu Mei Kato
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Principal Investigator: Shumei Kato, MD University of California, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Shu Mei Kato, Associate Clinical Professor of Medicine, University of California, San Diego Identifier: NCT02478931    
Other Study ID Numbers: 130794
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No