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Randomized optimal selection design for dose optimization
Date: October 8, 2025 PMID: PMC12505323 Category: N/A Authors: Shuqi Wang, Ying Yuan, Suyu Liu Abstract: The US Food and Drug Administration (FDA) launched Project Optimus to shift the objective of dose selection from the maximum tolerated dose to the optimal biological dose (OBD), optimizing the benefit-risk tradeoff. One approach recommended by the FDA's guidance is to conduct randomized trials comparing multiple doses. In this paper, using the selection design framewo
bgtaylor1
Nov 112 min read
stImage: a versatile framework for optimizing spatial transcriptomic analysis through customizable deep histology and location informed integration
Date: August 31, 2025 PMID: PMC12409783 Category: N/A Authors: Yu Wang, Haichun Yang, Ruining Deng, Yuankai Huo, Qi Liu, Yu Shyr, Shilin Zhao Abstract: 40905789 Spatial transcriptomics (ST) integrates gene expression data with the spatial organization of cells and their associated histology, offering unprecedented insights into tissue biology. While existing methods incorporate either location-based or histology-informed information, none fully synergize gene expression, hist
bgtaylor1
Nov 111 min read
Hematuria Cancer Risk Score in Combination With Oncuria-Detect for Patients Undergoing Evaluation for Hematuria
Date: August 20, 2025 PMID: PMC12578602 Category: N/A Authors: John R Heard, Ian Pagano, Charles Rosser, Wei Shen Tan Abstract: 40846188 Objective: To evaluate the performance the Hematuria Cancer Risk Score (HCRS) in combination with the urine-based biomarker test Oncuria-Detect for the detection of bladder cancer in a cohort of patients referred for hematuria evaluation. Methods: A cohort of 365 patients undergoing microscopic and gross hematuria evaluation were prospective
bgtaylor1
Nov 112 min read
BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations
Date: August 19, 2025 PMID: 10.1007/s43441-025-00860-5 Category: N/A Authors: Xiaohan Chi, Ying Yuan, Ruitao Lin Abstract: 40830695 Background: Personalized cancer treatment using combination therapies offers substantial therapeutic benefits over single-agent treatments in most cancers. However, unmet clinical needs and increasing market competition pressure drug developers to quickly optimize combination doses and clearly demonstrate the contribution of each component when d
bgtaylor1
Nov 112 min read
Expanded Performance Comparison of the Oncuria 10-Plex Bladder Cancer Urine Assay Using Three Different Luminex xMAP Instruments
Date: July 10, 2025 PMID: PMC12294033 Category: N/A Authors: Sunao Tanaka, Takuto Shimizu, Ian Pagano, Wayne Hogrefe, Sherry Dunbar, Charles J Rosser, Hideki Furuya Abstract: 40722499 Background/Objectives : The clinically validated multiplex Oncuria bladder cancer (BC) assay quickly and noninvasively identifies disease risk and tracks treatment success by simultaneously profiling 10 protein biomarkers in voided urine samples. Oncuria uses paramagnetic bead-based fluorescence
bgtaylor1
Nov 112 min read
BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization
Date: August 22, 2025 PMID: PMC12240483 Category: N/A Authors: Yixuan Zhao, Rachael Liu, Jianchang Lin, Ying Yuan Abstract: 40626646 One common approach for dose optimization is a two-stage design, which initially conducts dose escalation to identify the maximum tolerated dose, followed by a randomization stage where patients are assigned to two or more doses to further assess and compare their risk-benefit profiles to identify the optimal dose. A limitation of this approach
bgtaylor1
Nov 112 min read
Pancreatic islet β-cell subtypes are derived from biochemically-distinct and nutritionally-regulated islet progenitors
Date: July 1, 2025 PMID: PMC12217943 Category: N/A Authors: Monica E Brown, Verda E Miranda, Simone Nevills, Ruiying Hu, Prasanna K Dadi, Alan J Simmons, Yanwen Xu, Yilin Yang, Mahircan Yagan, Sadia Najam, Leesa L Sampson, Mark A Magnuson, David A Jacobson, Ken S Lau, Emily Hodges, Guoqiang Gu Abstract: 40593675 Endocrine islet β cells comprise heterogenous subtypes with different gene expression and function levels. Here we study when/how this heterogeneity is induced and ho
bgtaylor1
Nov 112 min read
Performance of the Oncuria-Detect bladder cancer test for evaluating patients presenting with haematuria: results from a real-world clinical setting
Date: June 18, 2025 PMID: PMC12178018 Category: N/A Authors: Ian Pagano, Zhen Zhang, Michael Luu, Sergei Tikhonenkov, Florence Le Calvez-Kelm, Steve Goodison, Toru Sakatani, Kaoru Murakami, Takashi Kobayashi, Patrice Avogbe, Howard Kim, Riko Lee, Arnaud Manel, Emmanuel Vian, Charles J Rosser, Hideki Furuya Abstract: 40533776 Background: Bladder cancer is the 9th most diagnosed cancer worldwide with high incidences reported in Europe and the United States. Here, we evaluated t
bgtaylor1
Nov 112 min read
Practical Considerations for Using the TITE-BOIN Design to Handle Late-Onset Toxicity or Fast Accrual in Phase I Trials
Date: July 1, 2025 PMID: PMC12213182 Category: N/A Authors: Paste in the author's names... Abstract: 40327336 Conducting phase I trials is particularly challenging when dealing with late-onset dose-limiting toxicity (DLT) or when patient accrual is rapid relative to the DLT assessment window. In such cases, a new cohort may be ready for enrollment before the DLT assessments are complete for the current cohort, complicating dose assignment decisions. The time-to-event Bayesian
bgtaylor1
Nov 112 min read
PS-SAM: propensity-score-integrated self-adapting mixture prior to dynamically and efficiently borrow information from historical data
Date: October 2025 PMID: PMC12353383 Category: N/A Authors: Yuansong Zhao, Peng Yang, Glen Laird, Josh Chen, Ying Yuan Abstract: 40243184 There has been growing interest in incorporating historical data to improve the efficiency of randomized controlled trials (RCTs) or reduce their required sample size. A key challenge is that the patient characteristics of the historical data may differ from those of the current RCT. To address this issue, a well-known approach is to e
bgtaylor1
Nov 112 min read
Overexpression of fibroblast activation protein (FAP) in the stroma of proliferative inflammatory atrophy (PIA) and primary adenocarcinoma of the prostate
Date: August 5, 2025 PMID: PMC12534906 Category: N/A Authors: Fernanda Caramella-Pereira, Qizhi Zheng, Jessica L Hicks, Sujayita Roy, Tracy Jones, Martin Pomper, Lizamma Antony, Alan K Meeker, Srinivasan Yegnasubramanian, Angelo M De Marzo, W Nathaniel Brennen Abstract: 40187966 Fibroblast activation protein (FAP) is a serine protease upregulated at sites of tissue remodelling and cancer that represents a promising therapeutic and molecular imaging target. In prostate cancer,
bgtaylor1
Nov 112 min read
Targeting PIKfyve-driven lipid metabolism in pancreatic cancer
Date: June 2025 PMID: PMC12176661 Category: N/A Authors: Caleb Cheng, Jing Hu, Rahul Mannan, Tongchen He, Rupam Bhattacharyya, Brian Magnuson, Jasmine P Wisniewski, Sydney Peters, Saadia A Karim, David J MacLean, Hüseyin Karabürk, Li Zhang, Nicholas J Rossiter, Yang Zheng, Lanbo Xiao, Chungen Li, Dominik Awad, Somnath Mahapatra, Yi Bao, Yuping Zhang, Xuhong Cao, Zhen Wang, Rohit Mehra, Pietro Morlacchi, Vaibhav Sahai, Marina Pasca di Magliano, Yatrik M Shah, Lois S Weisman, J
bgtaylor1
Nov 42 min read
A MULTIPLEX DIAGNOSTIC GENE EXPRESSION SIGNATURE STRATIFIES MUSCLE INVASIVE BLADDER CANCER INTO RESPONDERS VS. NON-RESPONDERS TO NEOADJUVANT CHEMOTHERAPY
Date: April 23, 2025 DOI: 10.1097/01.JU.0001109980.27536.57.34 Category: N/A Authors: Dai, YF (Dai, Yunfeng) ; Sakatani, T (Sakatani, Toru) ; Tanaka, S (Tanaka, Sunao) ; Black, P (Black, Peter) ; Rosser, CJ (Rosser, Charles J.) ; Furuya, H (Furuya, Hideki) Abstract: IP14-34 INTRODUCTION AND OBJECTIVE: Bladder cancer is a biologically heterogeneous disease with variable clinical presentation, outcome and response to therapy. Thus, the clinical utility of a single biomarker for
bgtaylor1
Nov 42 min read
Spatial mapping of transcriptomic plasticity in metastatic pancreatic cancer
Date: June 2025 PMID: 40269162 Category: N/A Authors: Guangsheng Pei, Jimin Min, Kimal I Rajapakshe, Vittorio Branchi, Yunhe Liu, Benson Chellakkan Selvanesan, Fredrik Thege, Dorsay Sadeghian, Daiwei Zhang, Kyung Serk Cho, Yanshuo Chu, Enyu Dai, Guangchun Han, Mingyao Li, Cassian Yee, Kazuki Takahashi, Bharti Garg, Herve Tiriac, Vincent Bernard, Alexander Semaan, Jean L Grem, Thomas C Caffrey, Jared K Burks, Andrew M Lowy, Andrew J Aguirre, Paul M Grandgenett, Michael A Holli
bgtaylor1
Nov 42 min read
Blebbisomes are large, organelle-rich extracellular vesicles with cell-like properties
Date: March 2025 PMID: PMC11906356 Category: N/A Authors: Dennis K Jeppesen, Zachary C Sanchez, Noah M Kelley, James B Hayes, Jessica Ambroise, Emma N Koory, Evan Krystofiak, Nilay Taneja, Qin Zhang, Matthew M Dungan, Olivia L Perkins, Matthew J Tyska, Ela W Knapik, Kevin M Dean, Amanda C Doran, Robert J Coffey, Dylan T Burnette Abstract: 39984653 Cells secrete a large variety of extracellular vesicles (EVs) to engage in cell-to-cell and cell-to-environment intercellular comm
bgtaylor1
Nov 42 min read
Targeting PIKfyve-driven lipid metabolism in pancreatic cancer
Date: June 2025 PMID: PMC12176661 Category: N/A Authors: Caleb Cheng, Jing Hu, Rahul Mannan, Tongchen He, Rupam Bhattacharyya, Brian Magnuson, Jasmine P Wisniewski, Sydney Peters, Saadia A Karim, David J MacLean, Hüseyin Karabürk, Li Zhang, Nicholas J Rossiter, Yang Zheng, Lanbo Xiao, Chungen Li, Dominik Awad, Somnath Mahapatra, Yi Bao, Yuping Zhang, Xuhong Cao, Zhen Wang, Rohit Mehra, Pietro Morlacchi, Vaibhav Sahai, Marina Pasca di Magliano, Yatrik M Shah, Lois S Weisman, J
bgtaylor1
Nov 42 min read
Integration of lipidomics with targeted, single cell, and spatial transcriptomics defines an unresolved pro-inflammatory state in colon cancer
Date: March 6, 2025 PMID: PMC11885055 Category: N/A Authors: Ramani Soundararajan, Michelle M Maurin, Jetsen Rodriguez-Silva, Gunjan Upadhyay, Ashley J Alden, Siddabasave Gowda B Gowda, Michael J Schell, Mingli Yang, Noah Jhad Levine, Divyavani Gowda, Punith M Sundaraswamy, Shu-Ping Hui, Lance Pflieger, Heiman Wang, Jorge Marcet, Carolina Martinez, Robert David Bennett, Allen Chudzinski, Andreas Karachristos, Timothy M Nywening, Paul M Cavallaro, Matthew Linley Anderson, Robe
bgtaylor1
Nov 42 min read
Caspase-1-dependent pyroptosis converts αSMA+ CAFs into collagen-IIIhigh iCAFs to fuel chemoresistant cancer stem cells
Date: June 13, 2025 PMID: PMC12154229 Category: N/A Authors: Hongbo Gao, Stephen Q R Wong, Ethan Subel, Yung Hsing Huang, Yu-Cheng Lee, Kazukuni Hayashi, Mark Ellie Alonzo, Mustafa Karabicici, Xen Ping Hoi, Armine Kasabyan 1, Qianxing Mo, Zachary Melchiode, Ziad El-Zaatari, Steven Shen, Raj Satkunasivam, Fotis Nikolos, Keith Syson Chan Abstract: 40498841 The impact of chemotherapy-induced tumor cell pyroptosis on fibroblasts, a key stromal cell type within the tumor microenvi
bgtaylor1
Nov 42 min read
Oncogenic and tumor-suppressive forces converge on a progenitor-orchestrated niche to shape early tumorigenesis
Date: June 12, 2025 PMID: https://pmc.ncbi.nlm.nih.gov/articles/PMC12259082/ Category: N/A Authors: José Reyes, Isabella Del Priore, Andrea C Chaikovsky, Nikhita Pasnuri, Ahmed M Elhossiny, Tobias Krause, Andrew Moorman, Catherine Snopkowski, Meril Takizawa, Cassandra Burdziak, Nalin Ratnayeke, Ignas Masillioni, Yu-Jui Ho, Ronan Chaligné, Paul B Romesser, Aveline Filliol, Tal Nawy, John P Morris, Zhen Zhao, Marina Pasca Di Magliano, Direna Alonso-Curbelo, Dana Pe'er, Scott W
bgtaylor1
Nov 42 min read
Thor: a platform for cell-level investigation of spatial transcriptomics and histology
Date: August 5, 2025 PMID: https://pmc.ncbi.nlm.nih.gov/articles/PMC12325965/ Category: N/A Authors: Pengzhi Zhang, Weiqing Chen, Tu N Tran, Minghao Zhou, Kaylee N Carter, Ibrahem Kandel, Shengyu Li, Xen Ping Hoi, Yuxing Sun, Li Lai, Keith Youker, Qianqian Song, Yu Yang, Fotis Nikolos, Zejuan Li, Keith Syson Chan, John P Cooke, Guangyu Wang Abstract: 40764306 Spatial transcriptomics links gene expression with tissue morphology, however, current tools often prioritize genomic
bgtaylor1
Nov 42 min read
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