Predictive Genomic Biomarkers of Hormonal Therapy Versus Chemotherapy Benefit in Metastatic Castration-resistant Prostate Cancer

Authors: Graf, Ryon P., Fisher, Virginia, Mateo, Joaquin, Gjoerup, Ole V., Madison, Russell W., Raskina, Kira, Tukachinsky, Hanna, Creeden, James, Cunningham, Rachel, Huang, Richard S.P., Mata, Douglas A., Ross, Jeffrey S., Oxnard, Geoffrey R., Venstrom, Jeffrey M., Zurita, Amado J.

Source: European urology. 81(1):37-47

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100154225862.0x000001&indx=1&recIds=ETOCvdc_100154225862.0x000001

Clinicopathologic and Genomic Landscape of Breast Carcinoma Brain Metastases

Authors: Huang, Richard S.P., Haberberger, James, McGregor, Kimberly, Mata, Douglas A., Decker, Brennan, Hiemenz, Matthew C., Lechpammer, Mirna, Danziger, Natalie, Schiavone, Kelsie, Creeden, James, Graf, Ryon P., Strowd, Roy, Lesser, Glenn J., Razis, Evangelia D., Bartsch, Rupert, Giannoudis, Athina, Bhogal, Talvinder, Lin, Nancy U., Pusztai, Lajos, Ross, Jeffrey S., Palmieri, Carlo, Ramkissoon, Shakti H.

Source: Oncologist. 26(10):835-844

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100131000578.0x000001&indx=1&recIds=ETOCvdc_100131000578.0x000001

Clinicopathologic and Genomic Characterization of PD‐L1 Positive Urothelial Carcinomas

Authors: Huang, Richard S.P., Haberberger, James, Harries, Lukas, Severson, Eric, Duncan, Daniel L., Ferguson, N. Lynn, Hemmerich, Amanda, Edgerly, Claire, Murugesan, Karthikeyan, Xiao, Jinpeng, McEwan, Deborah, Holmes, Oliver, Hiemenz, Matthew, Venstrom, Jeffrey, Elvin, Julia A., Creeden, James, Lin, Douglas I., Ross, Jeffrey S., Ramkissoon, Shakti H.

Source: Oncologist. 26(5):375-382

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100121317316.0x000001&indx=1&recIds=ETOCvdc_100121317316.0x000001

Stakeholders' expectations of precision medicine: A qualitative study to identify areas of (mis)alignment

Authors: Knott, Tanya, Creeden, James, Horbach, Benjamin, Rauch‐Zumbrägel, Maximiliane, Vat, Lidewij, Harnik, Helena, Maravic, Zorana

Source: Health science reports. 6(8)

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100191763403.0x000001&indx=1&recIds=ETOCvdc_100191763403.0x000001

Clinical and analytical validation of FoundationOne^®CDx, a comprehensive genomic profiling assay for solid tumors.

Authors: Milbury, Coren A.¹ (AUTHOR), Creeden, James² (AUTHOR) jcreeden@foundationmedicine.com, Yip, Wai-Ki¹ (AUTHOR), Smith, David L.³ (AUTHOR), Pattani, Varun¹ (AUTHOR), Maxwell, Kristi⁴ (AUTHOR), Sawchyn, Bethany⁵ (AUTHOR), Gjoerup, Ole⁵ (AUTHOR), Meng, Wei¹ (AUTHOR), Skoletsky, Joel¹ (AUTHOR), Concepcion, Alvin D.¹ (AUTHOR), Tang, Yanhua¹ (AUTHOR), Bai, Xiaobo¹ (AUTHOR), Dewal, Ninad¹ (AUTHOR), Ma, Pei¹ (AUTHOR), Bailey, Shannon T.¹ (AUTHOR), Thornton, James¹ (AUTHOR), Pavlick, Dean C.⁶ (AUTHOR), Frampton, Garrett M.⁶ (AUTHOR), Lieber, Daniel⁷ (AUTHOR)

Source: PLoS ONE. 3/16/2022, Vol. 17 Issue 3, p1-37. 37p.

Subject Terms: *COMPANION diagnostics, *DRUG labeling, *TUMOR markers, *CANCER genes, *CANCER prognosis, *HETEROZYGOSITY, *BIOMARKERS

Geographic Terms: UNITED States

Company/Entity: UNITED States. Food & Drug Administration

Insights of Clinical Significance From 109 695 Solid Tumor Tissue-Based Comprehensive Genomic Profiles.

Authors: Heilmann, Andreas M, Riess, Jonathan W, McLaughlin-Drubin, Margaret, Huang, Richard S P, Hjulstrom, Meghann, Creeden, James, Alexander, Brian M, Erlich, Rachel L

Source: Oncologist; Feb2024, Vol. 29 Issue 2, pe224-e236, 13p

Subject Terms: TUMOR diagnosis, TUMOR treatment, TISSUE analysis, CLINICAL pathology, SCIENTIFIC observation, GENETIC mutation, SEQUENCE analysis, ONCOGENES, CARCINOGENESIS, RETROSPECTIVE studies, ACQUISITION of data, INDIVIDUALIZED medicine, MEDICAL protocols, CANCER patients, GENOMICS, GENE expression profiling, DECISION making, DIAGNOSIS, MEDICAL records, RESEARCH funding, DECISION making in clinical medicine, TUMOR markers, TUMORS, IMMUNOTHERAPY

Identification and Utilization of Biomarkers to Predict Response to Immune Checkpoint Inhibitors

Authors: Gjoerup, Ole, Brown, Charlotte A., Ross, Jeffrey S., Huang, Richard S. P., Schrock, Alexa, Creeden, James, Fabrizio, David, Tolba, Khaled

Source: AAPS journal. 22(6)

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100187146705.0x000001&indx=1&recIds=ETOCvdc_100187146705.0x000001

Are there financial savings associated with supplementing current diagnostic practice for preeclampsia with a novel test? Learnings from a modeling analysis from a German payer perspective

Authors: Hadker, Nandini, Garg, Suchita, Costanzo, Cory, van der Helm, Wim, Creeden, James

Source: Hypertension in pregnancy. 32(2):105-119

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100105838766.0x000001&indx=1&recIds=ETOCvdc_100105838766.0x000001

Building bridges to the future of medicine: recommendations for boosting development of novel and companion diagnostics

Authors: Creeden, James

Source: Pharmacogenomics. 13(14):1651-1659

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100121257532.0x000001&indx=1&recIds=ETOCvdc_100121257532.0x000001

Clinicopathologic and Genomic Landscape of Non-Small Cell Lung Cancer Brain Metastases.

Authors: Huang, Richard S P, Harries, Lukas, Decker, Brennan, Hiemenz, Matthew C, Murugesan, Karthikeyan, Creeden, James, Tolba, Khaled, Stabile, Laura P, Ramkissoon, Shakti H, Burns, Timothy F, Ross, Jeffrey S

Source: Oncologist; Oct2022, Vol. 27 Issue 10, p839-848, 10p, 2 Diagrams, 2 Charts, 2 Graphs

Subject Terms: LUNG cancer, GENETIC mutation, IMMUNOHISTOCHEMISTRY, METASTASIS, RETROSPECTIVE studies, BRAIN tumors, GENOMICS, GENE expression profiling, TUMOR markers, LONGITUDINAL method

Pan-cancer analysis of CD274 (PD-L1) mutations in 314, 631 patient samples and subset correlation with PD-L1 protein expression.

Authors: Huang, Richard S.P., Decker, Brennan, Murugesan, Karthikeyan, Hiemenz, Matthew, Mata, Douglas A., Li, Gerald, Creeden, James, Ramkissoon, Shakti H., Ross, Jeffrey S.

Source: Journal of clinical oncology. 39(15 suppl):2605-2605

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100173186611.0x000001&indx=1&recIds=ETOCvdc_100173186611.0x000001

Real-world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm).

Authors: Rugo, Hope S., Raskina, Kira, Schrock, Alexa Betzig, Israel, Mason A., Sokol, Ethan, Sivakumar, Smruthy, Ward, Ashley, Creeden, James, Oxnard, Geoffrey R., McGregor, Kimberly, Venstrom, Jeffrey Michael, Tukachinsky, Hanna

Source: Journal of clinical oncology. 39(15 suppl):1068-1068

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100173179076.0x000001&indx=1&recIds=ETOCvdc_100173179076.0x000001

Tumor Mutational Burden as a Predictor of First-Line Immune Checkpoint Inhibitor Versus Carboplatin Benefit in Cisplatin-Unfit Patients With Urothelial Carcinoma.

Authors: Graf, Ryon P., Fisher, Virginia, Huang, Richard S.P., Hamdani, Omar, Gjoerup, Ole V., Stanke, Jennifer, Creeden, James, Levy, Mia A., Oxnard, Geoffrey R., Gupta, Shilpa

Source: JCO Precision Oncology; 8/17/2022, Vol. 6, p1-12, 12p

Subject Terms: IMMUNE checkpoint inhibitors, TRANSITIONAL cell carcinoma, IPILIMUMAB, CARBOPLATIN, PROGRESSION-free survival, CANCER patients

Company/Entity: UNITED States. Food & Drug Administration

STRN-ALK Fusion–Positive Case of Breast Cancer With Response to Alectinib.

Authors: Kelly, Andrew D., Wiklund, Tom, Kononen, Juha, Creeden, James

Source: JCO Precision Oncology; 8/11/2021, Vol. 5, p1281-1284, 4p

Subject Terms: HEREDITARY nonpolyposis colorectal cancer, HORMONE receptor positive breast cancer, ANAPLASTIC large-cell lymphoma, CIRCULATING tumor DNA, BREAST cancer, NON-small-cell lung carcinoma

Genomic Profiling of Circulating Tumor DNA From Cerebrospinal Fluid to Guide Clinical Decision Making for Patients With Primary and Metastatic Brain Tumors.

Authors: Ramkissoon, Lori A., Pegram, Worthy, Haberberger, James, Danziger, Natalie, Lesser, Glenn, Strowd, Roy, Dahiya, Sonika, Cummings, Thomas J., Bi, Wenya Linda, Abedalthagafi, Malak, Sathyan, Pratheesh, McGregor, Kimberly, Reddy, Prasanth, Severson, Eric, Williams, Erik, Lin, Douglas, Edgerly, Claire, Huang, Richard S. P., Hemmerich, Amanda, Creeden, James

Source: Frontiers in Neurology; 10/19/2020, Vol. 11, pN.PAG-N.PAG, 9p

Subject Terms: CIRCULATING tumor DNA, PATIENT decision making, CEREBROSPINAL fluid, BRAIN tumors, CENTRAL nervous system tumors, CENTRAL nervous system, OPERATIVE surgery

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A Systematic Review of Serum Biomarkers Anti-Cyclic Citrullinated Peptide and Rheumatoid Factor as Tests for Rheumatoid Arthritis.

Authors: Taylor, Peter, Gartemann, Juliane, Hsieh, Jeanie, Creeden, James

Source: Autoimmune Diseases (2090-0422); 2011, p1-18, 18p, 2 Diagrams, 5 Charts

Subject Terms: RHEUMATOID factor, RHEUMATOID arthritis, BIOMARKERS, PEPTIDES, METHOTREXATE, AUTOANTIBODIES

EPMA-World Congress 2015: Bonn, Germany. 3-5 September 2015

Authors: Abraham, Jella-Andrea, Golubnitschaja, Olga, Akhmetov, Ildar, Andrews, Russell J., Quintana, Leonidas, Baban, Babak, Liu, Jun Yao, Qin, Xu, Wang, Tailing, Mozaffari, Mahmood S., Bati, Viktoriia V., Meleshko, Tamara V., Levchuk, Olga B., Boyko, Nadiya V., Bauer, Joanna, Boerner, Ewa, Podbielska, Halina, Bomba, Alojz, Petrov, Viktor O., Drobnych, Volodymyr G., Bubnov, Rostyslav V., Bykova, Oksana M., Brunner-La Rocca, Hans-Peter, Fleischhacker, Lutz, Heemskerk, Frank, Helms, Thomas, Jaarsma, Tiny, Kinkorová, Judita, Ramaekers, Jan, Ruff, Peter, Schnur, Ivana, Vanoli, Emilio, Verdu, Jose, Grabovetskyi, Sergiy A., Mykhalchenko, Olena M., Tymoshok, Natalia O., Shcherbakov, Oleksandr B., Semeniv, Igor P., Spivak, Mykola Y., Ostapenko, Tetyana V., Kobyliak, Nazarii M., Zholobak, Nadiya M., Spivak, Mykola Ya., Cauchi, John Paul, Cherepakhin, Dmitrii, Bakay, Marina, Borovikov, Artem, Suchkov, Sergey, Cieślik, Barbara, Migasiewicz, Agnieszka, Podbielska, Maria-Luiza, Pelleter, Markus, Giemza, Agnieszka, Cirak, Sebahattin, Del Re, Marzia, Bordi, Paola, Citi, Valentina, Palombi, Marta, Pinto, Carmine, Tiseo, Marcello, Danesi, Romano, Einhorn, Lukas, Fazekas, Judit, Muhr, Martina, Schoos, Alexandra, Panakova, Lucia, Herrmann, Ina, Manzano-Szalai, Krisztina, Oida, Kumiko, Singer, Josef, Jensen-Jarolim, Erika, Elnar, Arpiné A., Ouamara, Nadia, Boyko, Nadiya, Coumoul, Xavier, Antignac, Jean-Philippe, Le Bizec, Bruno, Eppe, Gauthier, Renaut, Jenny, Bonn, Torsten, Guignard, Cédric, Ferrante, Margherita, Chiusano, Maria Liusa, Cuzzocrea, Salvatore, O’Keeffe, Gerard, Cryan, John, Bisson, Michelle, Barakat, Amina, Hmamouchi, Ihsane, Zawia, Nasser, Kanthasamy, Anumantha, Kisby, Glen E., Alves, Rui, Pérez, Oscar Villacañas, Burgard, Kim, Spencer, Peter, Bomba, Norbert, Haranta, Martin, Zaitseva, Nina, May, Irina, Grojean, Stéphanie, Body-Malapel, Mathilde, Harari, Florencia, Harari, Raul, Yeghiazaryan, Kristina, Calabrese, Vittorio, Nemos, Christophe, Soulimani, Rachid, Evsevyeva, Maria E., Mishenko, Elena A., Kumukova, Zurida V., Chudnovsky, Evgeniy V., Smirnova, Tatyana A., Ivanova, Ludmila V., Eremin, Michail V., Rostovtseva, Maria V., Koshel, Vladimir I., Sergeeva, Oksana V., Konovalova, Nadesgda M., Girotra, Shantanu, Debald, Manuel, Kuhn, Walther, Goncharenko, Vadym M., Lushchyk, Ulyana, Grech, Godfrey, Konieczka, Katarzyna, Erwich, Jan Jaap, Costigliola, Vincenzo, Gembruch, Ulrich, Beniuk, Vasyl O., Kalenska, Olga V., Melnychuk, Olga, Gorbacheva, Irina A., Orekhova, Lyudmila Y., Tachalov, Vadim V., Grechanyk, Olena I., Abdullaiev, Rizvan Ya., Hagan, Suzanne, Martin, Eilidh, Pearce, Ian, Oliver, Katherine, Haytac, Cenk, Salimov, Fariz, Yoksul, Servin, Kunin, Anatoly A., Moiseeva, Natalia S., Herrera-Imbroda, Bernardo, del Río-González, Sergio, Lara, Maria Fernanda, Angulo, Antonia, Machuca Santa-Cruz, Francisco Javier, Ionescu, John, Isamulaeva, Alfiya Z., Magomedov, Shamil Sh., Isamulaeva, Aida I., Josifova, Tatjana, Kapalla, Marko, Kubáň, Juraj, Kent, Anthony, Fisher, Tom, Dias, Tilak, Topolčan, Ondřej, Kohl, Matthias, Kurchenko, Andrii I., Beniuk, Vasyl A., Strokan, Andriy M., Kzhyshkowska, Julia, Gudima, Alexandru, Stankevich, Ksenia S., Filimonov, Victor D., Klüter, Harald, Mamontova, Evgeniya M., Tverdokhlebov, Sergei I., Lushchyk, Ulyana B., Novytskyy, Viktor V., Babii, Igor P., Lushchyk, Nadiya G., Riabets, Lyudmyla S., Legka, Ivanna I., Marcus-Kalish, Mira, Mitelpunkt, Alexis, Galili, Tal, Shachar, Neta, Benjamini, Yoav, Dereń, Ewelina, Kunin, Dmitry A., Ippolitov, Yury A., Morozov, Alexei N., Chirkova, Natalia V., Aliev, Nakhid T., Abdelsayed, Rafik, Shi, Xing-Ming, Novák, Jaroslav, Štork, Milan, Zeman, Václav, Oosterhuis, Wytze P., Theodorsson, Elvar, Kudryavtseva, Tatyana V., Isaeva, Elena R., Loboda, Ekaterina S., Pazzagli, Mario, Malentacchi, Francesca, Mancini, Irene, Brandslund, Ivan, Vermeersch, Pieter, Schwab, Matthias, Marc, Janja, van Schaik, Ron H. N., Siest, Gerard, Di Resta, Chiara, Pleva, Matus, Juhar, Jozef, Polívka jr., Jiří, Janků, Filip, Pešta, Martin, Doležal, Jan, Králíčková, Milena, Polívka, Jiří, Lukešová, Alena, Müllerová, Nina, Ševčík, Petr, Rohan, Vladimír, Richter, Kneginja, Miloseva, Lence, Niklewski, Günter, Acker, Jens, Niklewski, Guenter, Safonicheva, Olga, Sautin, Maxim, Sinelnikova, Janna, Secer, Songül, von Bandemer, Stephan, Shapira, Niva, Shcherbakov, Aleksandr, Shumilovich, Bogdan R., Lipkind, Zhanna, Vorobieva, Yulia, Sudareva, Anastasiia V., Smokovski, Ivica, Milenkovic, Tatjana, Solís-Herrera, Arturo, Arias-Esparza, María del Carmen, Sridhar, Krishna Chander, Studneva, Maria, Song, Sihong, Creeden, James, Мandrik, Мark, Tofail, Syed A. M., Fiala, Ondřej, Karlíková, Marie, Svobodová, Šárka, Kučera, Radek, Fuchsová, Radka, Třeška, Vladislav, Šimánek, Václav, Pecen, Ladislav, Šoupal, Jan, Svačina, Štěpán, Tretyak, Evgeniya, Trovato, Francesca M., Martines, Giuseppe Fabio, Brischetto, Daniela, Catalano, Daniela, Musumeci, Giuseppe, Trovato, Guglielmo M., Tsangaris, George Th., Anagnostopoulos, Athanasios K., Verdú, José, Gutiérrez, German, Rovira, Jordi, Martinez, Marta, Green, Donna, Garson, Arthur, Tamburini, Elena, Cuomo, Stefano, Martinez-Leon, Juan, Abrisqueta, Teresa, Arredondo, Teresa, Vera, Cecilia, Fico, Giuseppe, Arribas, Fernando, Onderco, Martina, Vara, Isabel, Sambo, Francesco, Di Camillo, Barbara, Cobelli, Claudio, Facchinetti, Andrea, Bellazzi, Riccardo, Sacchi, Lucia, Dagliati, Arianna, Segnani, Daniele, Tibollo, Valentina, Ottaviano, Manuel, Gabriel, Rafael, Groop, Leif, Postma, Jacqueline, Martinez, Antonio, Hakaste, Liisa, Tuomi, Tiinamaija, Zarkogianni, Konstantia, Volchek, Igor, Pototskaya, Nina, Petrov, Andrey, Pototskaya, Nadezhda, Voog-Oras, Ülle, Jagur, Oksana, Leibur, Edvitar, Niibo, Priit, Jagomägi, Triin, Nguyen, Minh Son, Pruunsild, Chris, Piikov, Dagmar, Saag, Mare, Wang, Wei, Weinhäusel, Andreas, Pulverer, Walter, Wielscher, Matthias, Hofner, Manuela, Noehammer, Christa, Soldo, Regina, Hettegger, Peter, Gyurjan, Istvan, Kulovics, Ronald, Schönthaler, Silvia, Beikircher, Gabriel, Kriegner, Albert, Pabinger, Stephan, Vierlinger, Klemens, Yüzbaşıoğlu, Ayşe, Özgüç, Meral, Fiebiger, Edda

Source: Abraham, J., O. Golubnitschaja, I. Akhmetov, R. J. Andrews, L. Quintana, B. Baban, J. Y. Liu, et al. 2016. “EPMA-World Congress 2015: Bonn, Germany. 3-5 September 2015.” The EPMA Journal 7 (Suppl 1): 9. doi:10.1186/s13167-016-0054-6. http://dx.doi.org/10.1186/s13167-016-0054-6.

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Relation: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896262/pdf/; The EPMA Journal

Access URL: http://nrs.harvard.edu/urn-3:HUL.InstRepos:27662156

Comparative Effectiveness of Immune Checkpoint Inhibitors vs Chemotherapy by Tumor Mutational Burden in Metastatic Castration-Resistant Prostate Cancer.

Authors: Graf, Ryon P., Fisher, Virginia, Weberpals, Janick, Gjoerup, Ole, Tierno, Marni B., Huang, Richard S. P., Sayegh, Nicolas, Lin, Douglas I., Raskina, Kira, Schrock, Alexa B., Severson, Eric, Haberberger, James F., Ross, Jeffrey S., Creeden, James, Levy, Mia A., Alexander, Brian M., Oxnard, Geoffrey R., Agarwal, Neeraj

Source: JAMA Network Open; 3/31/2022, Vol. 5 Issue 3, pe225394-e225394, 1p

Financial impact of a novel pre-eclampsia diagnostic test versus standard practice: a decision-analytic modeling analysis from a UK healthcare payer perspective

Authors: Hadker, Nandini, Garg, Suchita, Costanzo, Cory, Miller, Jeffrey D., Foster, Talia, van der Helm, Wim, Creeden, James

Source: Journal of Medical Economics; December 2010, Vol. 13 Issue: 4 p728-737, 10p