Study of Personalized Cancer Therapy to Determine Response and Toxicity

NCT02478931 | Recruiting

• 1 other identifier: 130794
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (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.

  4 years

Secondary Outcomes (1)

• Comparison of Tumor Biomarker Profiling to Toxicity Outcome

  4 years

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a diagnosis of cancer or a cancer-related condition

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shu Mei Kato: lead

Study Sites (3)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California, 92270, United States

RECRUITING

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 41567798 DERIVED

• 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.

  PMID: 40297627 DERIVED

• 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.

  PMID: 39220298 DERIVED

• 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.

  PMID: 37637234 DERIVED

• 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.

  PMID: 37619986 DERIVED

• 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.

  PMID: 36483582 DERIVED

• 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.

  PMID: 35238467 DERIVED

• 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.

  PMID: 34641956 DERIVED

• 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.

  PMID: 34375311 DERIVED

• 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.

  PMID: 33865203 DERIVED

• 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.

  PMID: 33427211 DERIVED

• 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.

  PMID: 32923144 DERIVED

• 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.

  PMID: 32881280 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue, ascites, stool, tracheal aspirate, and cerebral spinal fluid

MeSH Terms

Conditions

Neoplasms

Study Officials

• Shumei Kato, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Suzanna, MPH

CONTACT

(858) 534-1306; sml012@health.ucsd.edu

Michaela Doering, BS

CONTACT

(858) 657-7512; mdoering@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 23, 2015
• Study Start: September 5, 2013
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (3)