Study of Personalized Cancer Therapy to Determine Response and Toxicity

Официальное название

UCSD Profile Related Evidence Determining Individualized Cancer Therapy (UCSD PREDICT)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Comparison of Tumor Biomarker Profiling to Treatment Outcome [Срок оценки: 4 years]

Вторичные конечные точки (1)

• Comparison of Tumor Biomarker Profiling to Toxicity Outcome [Срок оценки: 4 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• UCSD Moores Cancer Center — La Jolla
• Eisenhower Medical Center, Lucy Curci Cancer Center — Rancho Mirage
• Rady Children's Hospital, San Diego — San Diego

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT02478931 · 130794

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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