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Trial record 1 of 1 for:    NCT02478931
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Study of Personalized Cancer Therapy to Determine Response and Toxicity (UCSD_PREDICT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Razelle Kurzrock, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02478931
First received: May 22, 2015
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 2000
Study Start Date: September 2013
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Detailed Description:
This is a non-therapeutic, 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

Inclusion Criteria:

  • Must be willing to provide informed consent

Exclusion Criteria:

  • Subjects unable to give informed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02478931

Contacts
Contact: Lee Suzanna, MPH (858) 534-1306 sml012@ucsd.edu
Contact: Michaela Doering, BS (858) 822-5127 mdoering@ucsd.edu

Locations
United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Razelle Kurzrock, MD University of California, San Diego
  More Information

Responsible Party: Razelle Kurzrock, MD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02478931     History of Changes
Other Study ID Numbers: 130794
Study First Received: May 22, 2015
Last Updated: June 20, 2016

ClinicalTrials.gov processed this record on April 28, 2017