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The availability of high-fidelity animal models for oncology research has grown enormously in recent years, enabling preclinical studies relevant to prevention, diagnosis, and treatment of cancer to be undertaken. This has led to increased opportunities to conduct co-clinical trials, which are studies on patients that are carried out parallel to or sequentially with animal models of cancer that mirror the biology of the patients' tumors. Patient-derived xenografts (PDX) and genetically engineered mouse models (GEMM) are considered to be the models that best represent human disease and have high translational value. Notably, one element of co-clinical trials that still needs significant optimization is quantitative imaging. The National Cancer Institute has organized a Co-Clinical Imaging Resource Program (CIRP) network to establish best practices for co-clinical imaging and to optimize translational quantitative imaging methodologies. This overview describes the ten co-clinical trials of investigators from eleven institutions who are currently supported by the CIRP initiative and are members of the Animal Models and Co-clinical Trials (AMCT) Working Group. Each team describes their corresponding clinical trial, type of cancer targeted, rationale for choice of animal models, therapy, and imaging modalities. The strengths and weaknesses of the co-clinical trial design and the challenges encountered are considered. The rich research resources generated by the members of the AMCT Working Group will benefit the broad research community and improve the quality and translational impact of imaging in co-clinical trials.
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http://dx.doi.org/10.3390/tomography9020053 | DOI Listing |
Genes Dis
September 2025
Key Laboratory of Chemical Biology & Traditional Chinese Medicine Research of Ministry of Education, Key Laboratory of Study and Discovery of Small Targeted Molecules of Hunan Province, Engineering Research Center of Reproduction and Translational Medicine of Hunan Province, Key Laboratory of Protei
Despite advancing therapeutic treatments, cancer remains the leading cause of death worldwide, with most of its patients developing drug resistance and recurrence after initial treatment. Therefore, incorporating preclinical models that mimic human cancer biology and drug responses is essential for improving treatment efficacy and prognosis. Patient-derived xenograft (PDX) models, as a promising and reliable preclinical trial platform, retain key features of the original tumor such as gene expression profiles, histopathological features, drug responses, and molecular signatures more faithfully compared with traditional tumor cell line models and cell line-derived xenograft models.
View Article and Find Full Text PDFClin Cancer Res
August 2025
Department of Human Genetics, University of California, Los Angeles, Los Angeles, California.
Purpose: We conducted a mouse-human co-clinical trial to evaluate the biological efficacy of exercise therapy in breast cancer prevention.
Patients And Methods: In a phase I randomized trial, 75 nonexercising women at high risk of breast cancer were allocated to receive (1:1 ratio) usual care or one of three exercise therapy dose regimens: 75, 150, or 300 minutes/week for 24 consecutive weeks. Biological efficacy was evaluated by changes in breast epithelial cell proliferation (Ki67).
BMJ Open
February 2025
Implementation Science, Novartis Pharmaceuticals UK, London, UK.
Objectives: VICTORION-Spirit was a hybrid study designed to assess the feasibility of implementing inclisiran, a novel cholesterol-lowering treatment and behavioural support within primary care centres in England. This process evaluation aimed to evaluate the implementation of inclisiran for patients with elevated low-density lipoprotein cholesterol and atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (n=900), from the perspectives of key stakeholders.
Design: VICTORION-Spirit was a phase IIIb, multicentre, randomised, controlled study.
BMJ Oncol
July 2024
Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Objective: To evaluate signal transducer and activator of transcription 3 (STAT3) inhibition we conducted a co-clinical trial testing danvatirsen, a STAT3 antisense oligonucleotide (ASO) and checkpoint inhibition in conjunction with preclinical experiments.
Methods And Analysis: Orthotopically implanted pancreatic cancer (pancreatic adenocarcinoma (PDAC)) was treated with STAT3 ASO with immune checkpoint inhibition. Tumour infiltrating immune cell populations were characterised via flow cytometry.
Heliyon
May 2024
Department of Laboratory Medicine, Clinical College of Yangzhou University and Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, 225001, China.
is a commonly mutated oncogene in human gastric cancer and is often associated with drug resistance and poor prognosis. Co-clinical trial of combined MEK-CDK4/6 inhibition in AS mutated cancers demonstrated therapeutic efficacy in patient-derived xenografts and safety in patients. Here, present research focuses on targeting CDK4/6 and MEK synergistically block the proliferation of -mutated gastric cancer cells in vitro and in vivo and induced autophagy through the AMPK/mTOR pathway.
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