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

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ClinicalTrials.gov Identifier: NCT02478931
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Shu Mei Kato, University of California, San Diego

Tracking Information
First Submitted Date May 22, 2015
First Posted Date June 23, 2015
Last Update Posted Date April 5, 2021
Actual Study Start Date September 5, 2013
Estimated Primary Completion Date September 5, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 18, 2015)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Personalized Cancer Therapy to Determine Response and Toxicity
Official Title UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine, tissue, ascites, stool, tracheal aspirate, and cerebral spinal fluid
Sampling Method Non-Probability Sample
Study Population All patients with a diagnosis of cancer or a cancer-related condition
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2019)
10000
Original Estimated Enrollment
 (submitted: June 18, 2015)
2000
Estimated Study Completion Date September 5, 2026
Estimated Primary Completion Date September 5, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lee Suzanna, MPH (858) 534-1306 sml012@health.ucsd.edu
Contact: Michaela Doering, BS (858) 657-7512 mdoering@health.ucsd.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02478931
Other Study ID Numbers 130794
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shu Mei Kato, University of California, San Diego
Study Sponsor Shu Mei Kato
Collaborators Not Provided
Investigators
Principal Investigator: Shumei Kato, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date April 2021