AzTrials
AzTrials

CancerUCSD_PREDICTNCT02478931

Study of Personalized Cancer Therapy to Determine Response and Toxicity

An observational study of Cancer, run by Shu Mei Kato at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 7 years and older
Conditions the study is for
Cancer
How many people
10,000 participants
Where
3 sitesUnited States
Study dates
5 Sep 2013to 5 Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients with a diagnosis of cancer or a cancer-related condition

Who may be able to join

  • Must be willing to provide informed consent, parent permission, or assent

Who cannot join

  • Subjects unable to give informed consent, parent permission, or assent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lee Suzanna, MPH contact

(858) 534-1306

sml012@health.ucsd.edu

Michaela Doering, BS contact

(858) 657-7512

mdoering@health.ucsd.edu

United States3 sites, 3 recruiting

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

    Suzanna Lee, 858-534-1306, sml012@ucsd.edu

    Recruiting

  • Eisenhower Medical Center, Lucy Curci Cancer Center

    Rancho Mirage, California, 92270

    Stephanie W Farrell, MBA, 760-837-8034, research@emc.org

    Henry Tsai, MD

    Recruiting

  • Rady Children's Hospital, San Diego

    San Diego, California, 92123

    Neera Gundrania, MPH, 858-966-8823, ngundrania@rchsd.org

    Dennis Kuo, MD

    Recruiting

Other trials in United States

About this study

Official title: UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)

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.

Read the 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.

Conditions
Cancer
Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 years

Secondary outcomes (1)

  1. 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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study start5 Sep 2013
  3. Primary completion5 Sep 2026 (estimated)
  4. Study completion5 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02478931
Sponsor's protocol ID
130794
Acronym
UCSD_PREDICT
Status last verified
Mar 2026
First submitted
22 May 2015
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Patwari A, Nishizaki D, Jensen T, DePietro P, Pabla S, Kato S, Kurzrock R. PD-L2 Landscape and Correlation with Outcome: An Immunomic Analysis. JCO Oncol Adv. 2026 Jan;3(1):e2500151. doi: 10.1200/oa-25-00151. Epub 2026 Jan 15.

    PubMed 41567798

  • Nikanjam M, Kato S, Nishizaki D, Barkauskas DA, Pabla S, Nesline MK, Conroy JM, Naing A, Kurzrock R. ICOS and ICOS ligand: expression patterns and outcomes in oncology patients. Ther Adv Med Oncol. 2025 Apr 24;17:17588359251330514. doi: 10.1177/17588359251330514. eCollection 2025.

    PubMed 40297627

  • Jeong AR, Trando AH, Thomas SD, Riviere P, Sakowski PJ, Sokol ES, Goodman AM, Kurzrock R. Higher tumor mutational burden and PD-L1 expression correlate with shorter survival in hematologic malignancies. Ther Adv Med Oncol. 2024 Aug 28;16:17588359241273053. doi: 10.1177/17588359241273053. eCollection 2024.

    PubMed 39220298

  • Castro A, Goodman AM, Rane Z, Talwar JV, Frampton GM, Morris GP, Lippman SM, Zhang X, Kurzrock R, Carter H. Autoimmune HLA Alleles and Neoepitope Presentation Predict Post-Allogenic Transplant Relapse. J Immunother Precis Oncol. 2023 May 15;6(3):127-132. doi: 10.36401/JIPO-22-19. eCollection 2023 Aug.

    PubMed 37637234

  • Jou J, Kato S, Miyashita H, Thangathurai K, Pabla S, DePietro P, Nesline MK, Conroy JM, Rubin E, Eskander RN, Kurzrock R. Cancer-Immunity Marker RNA Expression Levels across Gynecologic Cancers: Implications for Immunotherapy. Mol Cancer Ther. 2023 Nov 1;22(11):1352-1362. doi: 10.1158/1535-7163.MCT-23-0270.

    PubMed 37619986

  • Bevins NJ, Okamura R, Montesion M, Adashek JJ, Goodman AM, Kurzrock R. Tumor Infiltrating Lymphocyte Expression of PD-1 Predicts Response to Anti-PD-1/PD-L1 Immunotherapy. J Immunother Precis Oncol. 2022 Sep 22;5(4):90-97. doi: 10.36401/JIPO-22-9. eCollection 2022 Nov.

    PubMed 36483582

  • Louie BH, Kato S, Kim KH, Lim HJ, Lee S, Okamura R, Fanta PT, Kurzrock R. Precision medicine-based therapies in advanced colorectal cancer: The University of California San Diego Molecular Tumor Board experience. Mol Oncol. 2022 Jul;16(13):2575-2584. doi: 10.1002/1878-0261.13202. Epub 2022 Apr 8.

    PubMed 35238467

  • 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.

    PubMed 34641956

  • 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):e150453. doi: 10.1172/jci.insight.150453.

    PubMed 34375311

  • 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.

    PubMed 33865203

  • 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):e142547. doi: 10.1172/jci.insight.142547.

    PubMed 33427211

  • 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.

    PubMed 32923144

  • 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.

    PubMed 32881280

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Shu Mei Kato at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lee Suzanna, MPH ((858) 534-1306, sml012@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Tumor Biomarker Profiling to Treatment Outcome (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02478931, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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