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

• ClinicalTrials.gov Identifier: NCT02478931
• Recruitment Status: Recruiting
• First Posted: June 23, 2015
• Last Update Posted: April 5, 2021
• Sponsor: Shu Mei Kato
• 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

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 *

• Pham TV, Goodman AM, Sivakumar S, Frampton G, Kurzrock R. Intra-patient stability of tumor mutational burden from tissue biopsies at different time points in advanced cancers. Genome Med. 2021 Oct 12;13(1):159. doi: 10.1186/s13073-021-00979-8.
• Botta GP, Kato S, Patel H, Fanta P, Lee S, Okamura R, Kurzrock R. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021 Sep 22;6(18). pii: e150453. doi: 10.1172/jci.insight.150453.
• Kato S, Porter R, Okamura R, Lee S, Zelichov O, Tarcic G, Vidne M, Kurzrock R. Functional measurement of mitogen-activated protein kinase pathway activation predicts responsiveness of RAS-mutant cancers to MEK inhibitors. Eur J Cancer. 2021 May;149:184-192. doi: 10.1016/j.ejca.2021.01.055. Epub 2021 Apr 14.
• Kato S, Okamura R, Adashek JJ, Khalid N, Lee S, Nguyen V, Sicklick JK, Kurzrock R. Targeting G1/S phase cell-cycle genomic alterations and accompanying co-alterations with individualized CDK4/6 inhibitor-based regimens. JCI Insight. 2021 Jan 11;6(1). pii: 142547. doi: 10.1172/jci.insight.142547.
• Nikanjam M, Riviere P, Goodman A, Barkauskas DA, Frampton G, Kurzrock R. Tumor mutational burden is not predictive of cytotoxic chemotherapy response. Oncoimmunology. 2020 Jun 24;9(1):1781997. doi: 10.1080/2162402X.2020.1781997.
• Charo LM, Eskander RN, Okamura R, Patel SP, Nikanjam M, Lanman RB, Piccioni DE, Kato S, McHale MT, Kurzrock R. Clinical implications of plasma circulating tumor DNA in gynecologic cancer patients. Mol Oncol. 2021 Jan;15(1):67-79. doi: 10.1002/1878-0261.12791. Epub 2020 Sep 17.

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

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