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4. Temporal Stability and Prognostic Biomarker Potential of the Prostate Cancer Urine miRNA Transcriptome

Author

Jeon, Jouhyun, Olkhov-Mitsel, Ekaterina, Xie, Honglei, Yao, Cindy Q, Zhao, Fang, Jahangiri, Sahar, Cuizon, Carmelle, Scarcello, Seville, Jeyapala, Renu, Watson, John D, Fraser, Michael, Ray, Jessica, Commisso, Kristina, Loblaw, Andrew, Fleshner, Neil E, Bristow, Robert G, Downes, Michelle, Vesprini, Danny, Liu, Stanley, Bapat, Bharati, and Boutros, Paul C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Urologic Diseases, Clinical Research, Biotechnology, Aging, Prostate Cancer, Prevention, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Biomarkers, Tumor, Carcinogenesis, Cohort Studies, Humans, Longitudinal Studies, Male, MicroRNAs, Neoplasm Grading, Prognosis, Prostatic Neoplasms, Reproducibility of Results, Transcriptome, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundThe development of noninvasive tests for the early detection of aggressive prostate tumors is a major unmet clinical need. miRNAs are promising noninvasive biomarkers: they play essential roles in tumorigenesis, are stable under diverse analytical conditions, and can be detected in body fluids.MethodsWe measured the longitudinal stability of 673 miRNAs by collecting serial urine samples from 10 patients with localized prostate cancer. We then measured temporally stable miRNAs in an independent training cohort (n = 99) and created a biomarker predictive of Gleason grade using machine-learning techniques. Finally, we validated this biomarker in an independent validation cohort (n = 40).ResultsWe found that each individual has a specific urine miRNA fingerprint. These fingerprints are temporally stable and associated with specific biological functions. We identified seven miRNAs that were stable over time within individual patients and integrated them with machine-learning techniques to create a novel biomarker for prostate cancer that overcomes interindividual variability. Our urine biomarker robustly identified high-risk patients and achieved similar accuracy as tissue-based prognostic markers (area under the receiver operating characteristic = 0.72, 95% confidence interval = 0.69 to 0.76 in the training cohort, and area under the receiver operating characteristic curve = 0.74, 95% confidence interval = 0.55 to 0.92 in the validation cohort).ConclusionsThese data highlight the importance of quantifying intra- and intertumoral heterogeneity in biomarker development. This noninvasive biomarker may usefully supplement invasive or expensive radiologic- and tissue-based assays.

Published
2020

8. Implementation of HER2 Testing in Endometrial Cancer, a Summary of Real-World Initial Experience in a Large Tertiary Cancer Center.

Author

Plotkin, Anna, Olkhov-Mitsel, Ekaterina, Huang, Weei-Yuarn, and Nofech-Mozes, Sharon

Subjects
*CANCER treatment, *PREDICTIVE tests, *HUMAN services programs, *CANCER relapse, *ACADEMIC medical centers, *DISEASE management, *TERTIARY care, *TUMOR markers, *DECISION making in clinical medicine, *DESCRIPTIVE statistics, *ENDOMETRIAL tumors, *IMMUNOHISTOCHEMISTRY, *FEMALE reproductive organ tumors, *GENE expression, *ONCOGENES, *PATHOLOGICAL laboratories, *FLUORESCENCE in situ hybridization, *WOMEN'S health, *TREATMENT effect heterogeneity, *COLLECTION & preservation of biological specimens, *MEDICAL laboratories, *QUALITY assurance, *GENETIC testing, *SPECIALTY hospitals, *SENSITIVITY & specificity (Statistics)
Abstract

Simple Summary: In this study, scientists investigated how pathologists test for a protein called HER2 in a type of cancer called endometrial cancer (EC). They checked samples from 180 patients tested over the first two years following approval of the test in the clinic. They found that 28% of the samples had HER2 overexpression, which makes them eligible for HER2-targeted therapies. They also noticed that in some cases, the test results were different depending on the method used. This study shows that there are challenges in testing for HER2 in endometrial cancer and suggests that we need standardized guidelines to help doctors make better decisions about endometrial cancer treatment. HER2-targeted therapies have transformed the management of advanced or recurrent serous endometrial cancer (EC), leading to an increased clinical demand for HER2 testing. Despite its adoption in select academic centers, the global extent of such tumor testing is unclear. In this study, we report on the initial two-year experience of HER2 testing at a major academic center with a reference gynecologic oncology service and biomarker reference laboratory. All patients who underwent HER2 testing based on physician discretion, reflex HER2 testing, and reference laboratory requests were included. From February 2021 to October 2023, HER2 testing was performed on 192 tumor tissue samples from 180 EC patients. Serous carcinoma constituted 52% of samples, reflecting diagnostic challenges and limited therapeutic options for advanced EC. HER2 positivity was found in 28% of all cases and 30% of p53-aberrant cases. An immunohistochemistry (IHC) score of 3+ was found in 15% of samples, while IHC 2+ was found in 45% (13% IHC 2+/ISH+ and 32% IHC 2+/ISH−). The newly identified 'HER2-low' category comprised 46% of the samples. Heterogeneity was noted in 42% of HER2-positive cases, with complex patterns in 3%. NGS and HER2 IHC-FISH showed a 24% discordance, attributed to intratumoral heterogeneity, tumor cellularity, a small number of amplified cells, and the HER2/CEP17 ratio near the cut-off. This study offers real-world insights into HER2 testing in EC, highlighting the challenges and underscoring the need for standardized guidelines in specimen handling, proficiency testing, and scoring criteria to enhance patient management and therapeutic decision-making. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Mesonephric‐like adenocarcinoma of the female genital tract: novel observations and detailed molecular characterisation of mixed tumours and mesonephric‐like carcinosarcomas

Author

Mirkovic, Jelena, primary, Olkhov‐Mitsel, Ekaterina, additional, Amemiya, Yutaka, additional, Al‐Hussaini, Maysa, additional, Nofech‐Mozes, Sharon, additional, Djordjevic, Bojana, additional, Kupets, Rachel, additional, Seth, Arun, additional, and McCluggage, W Glenn, additional

Published
2023
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29. Cytohistologic immunohistochemical correlation of epithelial tubo‐ovarian neoplasms: Can cell blocks substitute for tissue?

Author

Lou, Si Kei, Hodgson, Anjelica, Nofech‐Mozes, Sharon, Schwock, Joerg, Olkhov‐Mitsel, Ekaterina, Mirkovic, Jelena, and Ghorab, Zeina

Abstract

Background: Cytologic specimens often represent the initial diagnostic material for tubo‐ovarian neoplasms resulting from therapeutic paracentesis for patients presenting with high‐volume ascites. However, subtyping and immunohistochemical (IHC) characterization, which have implications in preoperative management and downstream ancillary testing, are not routinely performed in many institutions. This study aims to perform cytohistologic correlation of commonly used IHC stains to establish their reliability in peritoneal fluids/washing specimens. Methods: A retrospective search of the laboratory information systems was performed to identify peritoneal fluid/washing specimens involved by borderline or malignant epithelial tubo‐ovarian neoplasms and concurrent/subsequent surgical resection specimens. Cell blocks and tissue were stained for PAX8, WT‐1, p53, p16, Napsin‐A, estrogen receptor, and progesterone receptor, and staining between cytological and surgical specimens was compared. Results: A total of 56 case pairs were included, with the following final diagnoses on histological examination: 37 high‐grade serous carcinomas, eight clear cell carcinomas, one endometrioid adenocarcinoma, two low‐grade serous carcinomas, and eight serous borderline tumors. There was perfect cytohistologic correlation for PAX8 (Lin's concordance correlation coefficient [LINCCC] = 1.00) and WT‐1 (LINCCC = 1.00), substantial/good correlation for p53 (LINCCC = 0.96), p16 (LINCCC = 0.93), napsin‐A (LINCCC = 0.91) and ER (LINCCC = 0.77), and moderate correlation for PR (LINCCC = 0.54). Conclusions: Immunohistochemical correlation between peritoneal fluid and surgical resection specimens for tubo‐ovarian neoplasms is high. Common subtypes of tubo‐ovarian carcinomas can be reliably distinguished on fluids using IHC. Cytohistologic correlation of immunohistochemistry (IHC) in tubo‐ovarian neoplasms is high. Common subtypes can be reliably distinguished on fluids using IHC. [ABSTRACT FROM AUTHOR]

Published
2023
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32. MP68-04 A FIVE—GENE DNA—METHYLATION BIOMARKER PANEL SENSITIVELY DETECTS BLADDER CANCER AND DISCRIMINATES BETWEEN HIGH—GRADE AND LOW—GRADE DISEASE IN VOIDED URINE

Author

Hermanns, Thomas, Olkhov-Mitsel, Ekaterina, Savio, Andrea, Gill, Bethany, Sykes, Jenna, Bhindi, Bimal, Juvet, Tristan, Kuk, Cynthia, Noon, Aidan, Rendon, Ricardo, Waltregny, David, van der Kwast, Theodorus H., Finelli, Antonio, Fleshner, Neil E., Lo, Kirk, Bapat, Bharati, and Zlotta, Alexandre R.

Published
2015
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33. MP61-01 FUNCTIONAL ROLE OF THE KALLIKREIN 6 REGION OF THE KALLIKREIN LOCUS IN GENETIC PREDISPOSITION FOR AGGRESSIVE (GLEASON ≥8) PROSTATE CANCER: FINE-MAPPING AND METHYLATION STUDY IN A CANADIAN COHORT AND THE SWISS ARM OF THE EUROPEAN RANDOMIZED STUDY FOR PROSTATE CANCER SCREENING

Author

Briollais, Laurent, Ozcelik, Hilmi, Kwiatkowski, Maciej, Xu, Jingxiong, Savas, Sevtap, Olkhov-Mitsel, Ekaterina, Recker, Franz, Kuk, Cynthia, Hanna, Sally, Fleshner, Neil E, Juvet, Tristan, Friedlander, Matt, Li, Hong, Chadwick, Karen, Trachtenberg, John, Toi, Ants, van der Kwast, Theodorus H, Diamandis, Eleftherios P, Bapat, Bharati, and Zlotta, Alexandre R.

Published
2015
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38. A noninvasive urine-based methylation biomarker panel to detect bladder cancer and discriminate cancer grade

Author

Hermanns, Thomas, primary, Savio, Andrea J., additional, Olkhov-Mitsel, Ekaterina, additional, Mari, Andrea, additional, Wettstein, Marian S., additional, Saba, Karim, additional, Bhindi, Bimal, additional, Kuk, Cynthia, additional, Poyet, Cédric, additional, Wild, Peter J., additional, Noon, Aidan, additional, Bashir, Shaheena, additional, Juvet, Tristan, additional, Rendon, Ricardo A., additional, Waltregny, David, additional, van der Kwast, Theodorus, additional, Finelli, Antonio, additional, Kulkarni, Girish S., additional, Fleshner, Neil E., additional, Lo, Kirk, additional, Bapat, Bharati, additional, and Zlotta, Alexandre R., additional

Published
2020
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41. An integrative DNA methylation model for improved prognostication of postsurgery recurrence and therapy in prostate cancer patients

Author

Jeyapala, Renu, primary, Kamdar, Shivani, additional, Olkhov-Mitsel, Ekaterina, additional, Savio, Andrea J, additional, Zhao, Fang, additional, Cuizon, Carmelle, additional, Liu, Richard SC, additional, Zlotta, Alexandre, additional, Fleshner, Neil, additional, van der Kwast, Theodorus, additional, and Bapat, Bharati, additional

Published
2020
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42. Methylation Markers in Prostate Biopsies Are Prognosticators for Late Biochemical Recurrence and Therapy after Surgery in Prostate Cancer Patients

Author

Savio, Andrea J., primary, Kamdar, Shivani, additional, Jeyapala, Renu, additional, Olkhov-Mitsel, Ekaterina, additional, Cuizon, Carmelle, additional, Finelli, Antonio, additional, Zlotta, Alexandre R., additional, Toi, Ants, additional, Fleshner, Neil E., additional, van der Kwast, Theodorus, additional, and Bapat, Bharati, additional

Published
2020
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43. Epigenome-Wide DNA Methylation Profiling Identifies Differential Methylation Biomarkers in High-Grade Bladder Cancer1

Author

Olkhov-Mitsel, Ekaterina, Savio, Andrea J., Kron, Ken J., Pethe, Vaijayanti V., Hermanns, Thomas, Fleshner, Neil E., van Rhijn, Bas W., van der Kwast, Theodorus H., Zlotta, Alexandre R., and Bapat, Bharati

Subjects
Original article
Abstract

Epigenetic changes, including CpG island hypermethylation, occur frequently in bladder cancer (BC) and may be exploited for BC detection and distinction between high-grade (HG) and low-grade (LG) disease. Genome-wide methylation analysis was performed using Agilent Human CpG Island Microarrays to determine epigenetic differences between LG and HG cases. Pathway enrichment analysis and functional annotation determined that the most frequently methylated pathways in HG BC were enriched for anterior/posterior pattern specification, embryonic skeletal system development, neuron fate commitment, DNA binding, and transcription factor activity. We identified 990 probes comprising a 32-gene panel that completely distinguished LG from HG based on methylation. Selected genes from this panel, EOMES, GP5, PAX6, TCF4, and ZSCAN12, were selected for quantitative polymerase chain reaction–based validation by MethyLight in an independent series (n = 84) of normal bladder samples and LG and HG cases. GP5 and ZSCAN12, two novel methylated genes in BC, were significantly hypermethylated in HG versus LG BC (P ≤ .03). We validated our data in a second independent cohort of LG and HG BC cases (n = 42) from The Cancer Genome Atlas (TCGA). Probes representing our 32-gene panel were significantly differentially methylated in LG versus HG tumors (P ≤ .04). These results indicate the ability to distinguish normal tissue from cancer, as well as LG from HG, based on methylation and reveal important pathways dysregulated in HG BC. Our findings were corroborated using publicly available data sets from TCGA. Ultimately, the creation of a methylation panel, including GP5 and ZSCAN12, able to distinguish between disease phenotypes will improve disease management and patient outcomes.

Published
2017

44. Additional file 1: of A urine-based DNA methylation assay, ProCUrE, to identify clinically significant prostate cancer

Author

Zhao, Fang, Olkhov-Mitsel, Ekaterina, Kamdar, Shivani, Jeyapala, Renu, Garcia, Julia, Hurst, Rachel, Hanna, Marcelino, Mills, Robert, Tuzova, Alexandra, O’Reilly, Eve, Kelly, Sarah, Cooper, Colin, Brewer, Daniel, Perry, Antoinette, Clark, Jeremy, Fleshner, Neil, and Bapat, Bharati

Subjects
musculoskeletal diseases, education
Abstract

Table S1. Correlations. Spearman’s rank correlations for the PMR values of each biomarker, ProCUrE, and clinical variables Spearman’s ρ *p

Published
2018
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45. Additional file 2: of A urine-based DNA methylation assay, ProCUrE, to identify clinically significant prostate cancer

Author

Zhao, Fang, Olkhov-Mitsel, Ekaterina, Kamdar, Shivani, Jeyapala, Renu, Garcia, Julia, Hurst, Rachel, Hanna, Marcelino, Mills, Robert, Tuzova, Alexandra, O’Reilly, Eve, Kelly, Sarah, Cooper, Colin, Brewer, Daniel, Perry, Antoinette, Clark, Jeremy, Fleshner, Neil, and Bapat, Bharati

Subjects
urologic and male genital diseases
Abstract

Figure S1. Diagnostic and prognostic ability of ProCUrE and age-adjusted PSA in the training cohort. Figure S2. Receiver operating characteristic curve analysis of training cohort for (A) benign vs PCa, clinically insignificant vs clinically significant PCa as determined by (B) GS, (C) CAPRA, and (D) Dâ Amico. (DOCX 291 kb)

Published
2018
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47. Temporal Stability and Prognostic Biomarker Potential of the Prostate Cancer Urine miRNA Transcriptome

Author

Jeon, Jouhyun, primary, Olkhov-Mitsel, Ekaterina, primary, Xie, Honglei, primary, Yao, Cindy Q, primary, Zhao, Fang, primary, Jahangiri, Sahar, primary, Cuizon, Carmelle, primary, Scarcello, Seville, primary, Jeyapala, Renu, primary, Watson, John D, primary, Fraser, Michael, primary, Ray, Jessica, primary, Commisso, Kristina, primary, Loblaw, Andrew, primary, Fleshner, Neil E, primary, Bristow, Robert G, primary, Downes, Michelle, primary, Vesprini, Danny, primary, Liu, Stanley, primary, Bapat, Bharati, primary, and Boutros, Paul C, primary

Published
2019
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50. PD18-07 A NON-INVASIVE URINE-BASED METHYLATION BIOMARKER PANEL FOR BLADDER CANCER DETECTION

Author

Hermanns*, Thomas, primary, Savio, Andrea J., additional, Olkhov-Mitsel, Ekaterina, additional, Mari, Andrea, additional, Saba, Karim, additional, Bhindi, Bimal, additional, Gill, Bethany, additional, Sykes, Jenna, additional, Kuk, Cynthia, additional, Poyet, Cedric, additional, Wild, Peter J., additional, Noon, Aidan, additional, Bashir, Shaheena, additional, Juvet, Tristan, additional, Rendon, Ricardo A., additional, Waltregny, David, additional, van der Kwast, Theodorus, additional, Finelli, Antonio, additional, Kulkarni, Girish S., additional, Fleshner, Neil E., additional, Lo, Kirk, additional, Bapat, Bharati, additional, and Zlotta, Alexandre R., additional

Published
2019
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