Understanding Who Benefits the Most from Interventions: Implications for Baseline Target Moderated Mediation Analysis with Multiple Moderators.

Recently, Baseline Target Moderated Mediation (BTMM) has received a lot of attention in the field of prevention science. Prevention scientists are interested in BTMM because the model goes beyond whether an intervention achieves effects but also details how and for whom the intervention is most effective. In BTMM, baseline measures are used to investigate potential baseline-by-treatment interactions.

Investigating started sample size, completed sample size and drop-out rate in 10 252 phase III clinical trials: Insights from ClinicalTrials.gov.

Aims: This study investigated the started sample size, completed sample size and drop-out rate of 10 252 published and unpublished phase III clinical trials registered on ClinicalTrials.gov over the past 20 years.

Methods: We conducted a comprehensive search on ClinicalTrials.

Pan-cancer γδ TCR analysis uncovers clonotype diversity and prognostic potential.

Gamma-delta T cells (γδ T cells) play a crucial role in both innate and adaptive immunity within tumors, yet their presence and prognostic value in cancer remain underexplored. This study presents a large-scale analysis of γδ T cell receptor (γδ TCR) reads from 11,000 tumor samples spanning 33 cancer types, utilizing the TRUST4 algorithm. Our findings reveal extensive diversity in γδ TCR clonality and gene expression, underscoring the potential of γδ T cells as prognostic biomarkers in various cancers.

A pan-cancer gamma delta T cell repertoire.

This report presents the largest collection of gamma-delta T cell receptor (γδ TCR) reads in human cancer to date, analyzing about 11,000 patient tumor samples across 33 cancer types using the TRUST4 algorithm. Despite γδ T cells being a small fraction of the T cell population, they play a key role in both innate and adaptive immunity. Our comprehensive analysis reveals their significant presence across all cancer types, specifically highlighting the diverse spectrum and clonality patterns of their γδ receptors.

JAK2/mTOR inhibition fails to prevent acute GVHD despite reduced Th1/Th17 cells: final phase 2 trial results.

Our phase 1 graft-versus-host disease (GVHD) prevention trial of JAK2 inhibitor, pacritinib (PAC; recommended phase 2 dose: 100 mg orally twice a day on day 0 to +70) plus sirolimus and tacrolimus (SIR/TAC) demonstrated the regimen was safe and free of pan-JAK myelosuppression after allogeneic hematopoietic cell transplantation (alloHCT). PAC inhibits interleukin 6 (IL-6) receptor activity and pathogenic T helper cell 1 (Th1)/Th17 differentiation in preclinical models and the phase 1 trial. Herein, we report on our completed phase 2 trial of PAC/SIR/TAC after 8/8 human leukocyte antigen matched alloHCT.

Breaking the silence of sharing data in medical research.

Data sharing is highly advocated in the scientific community, with numerous organizations, funding agencies, and journals promoting transparency and collaboration. However, limited research exists on actual data sharing practices. We conducted a comprehensive analysis of the intent to share individual participant data (IPD) in a total of 313,990 studies encompassing clinical trials and observational studies obtained from ClinicalTrials.

Autologous Hematopoietic Cell Transplantation Consolidation for First Response is Associated With Longer Survival Among Patients With Nodal Peripheral T Cell Lymphoma.

Nodal peripheral T cell lymphomas (PTCLs) are challenging subsets of non-Hodgkin lymphomas characterized by their heterogeneity and aggressive clinical behavior. Given the mixed outcomes reported in previous studies, the efficacy of autologous hematopoietic cell transplantation (auto-HCT) as a consolidation strategy following initial chemotherapy response remains uncertain. This study aims to evaluate the impact of upfront auto-HCT consolidation on overall survival (OS) and event-free survival (EFS) among patients with nodal PTCL who achieved a complete or partial response to initial chemotherapy.

Factors associated with overall survival in breast cancer patients with leptomeningeal disease (LMD): a single institutional retrospective review.

Background: Breast cancer-related leptomeningeal disease (BC-LMD) is a dire diagnosis for 5-8% of patients with breast cancer (BC). We conducted a retrospective review of BC-LMD patients diagnosed at Moffitt Cancer Center from 2011 to 2020, to determine the changing incidence of BC-LMD, factors which are associated with the progression of BC CNS metastasis to BC-LMD, and factors which are associated with OS for patients with BC-LMD.

Methods: Patients with BC and brain/spinal metastatic disease were identified.

A data-driven approach to choosing privacy parameters for clinical trial data sharing under differential privacy.

Objectives: Clinical trial data sharing is crucial for promoting transparency and collaborative efforts in medical research. Differential privacy (DP) is a formal statistical technique for anonymizing shared data that balances privacy of individual records and accuracy of replicated results through a "privacy budget" parameter, ε. DP is considered the state of the art in privacy-protected data publication and is underutilized in clinical trial data sharing.

Enhanced Efficacy of Chemotherapy by Addition of Immune Checkpoint Inhibitors in Stage IV Large Cell Neuroendocrine Carcinoma of the Lung: A Real-World Analysis.

Large Cell Neuroendocrine Carcinoma (LCNEC) is a high-grade malignancy with limited treatment options. Despite promising results of immunotherapy in non-small cell and small cell lung cancers, its benefit in LCNEC remains elusive. We included 24 patients diagnosed with stage IV LCNEC from the Moffitt Cancer Center database who received systemic therapy between January 2016 and May 2021.

The advantages of artificial intelligence-based gait assessment in detecting, predicting, and managing Parkinson's disease.

Background: Parkinson's disease is a neurological disorder that can cause gait disturbance, leading to mobility issues and falls. Early diagnosis and prediction of freeze episodes are essential for mitigating symptoms and monitoring the disease.

Objective: This review aims to evaluate the use of artificial intelligence (AI)-based gait evaluation in diagnosing and managing Parkinson's disease, and to explore the potential benefits of this technology for clinical decision-making and treatment support.

Factors improving overall survival in breast cancer patients with leptomeningeal disease (LMD): A single institutional retrospective review.

Background: Breast cancer-related leptomeningeal disease (BC-LMD) is a dire diagnosis for 5-8% of patients with breast cancer (BC). We conducted a retrospective review of BC-LMD patients diagnosed at Moffitt Cancer Center (MCC) from 2011-2020, to determine the changing incidence of BC-LMD, which factors impact progression of BC CNS metastasis to BC-LMD, and which factors affect OS for patients with BC-LMD.

Methods: Patients with BC and brain/spinal metastatic disease were identified.

Prediction-oriented prognostic biomarker discovery with survival machine learning methods.

Identifying novel and reliable prognostic biomarkers for predicting patient survival outcomes is essential for deciding personalized treatment strategies for diseases such as cancer. Numerous feature selection techniques have been proposed to address the high-dimensional problem in constructing prediction models. Not only does feature selection lower the data dimension, but it also improves the prediction accuracy of the resulted models by mitigating overfitting.

Risk factors associated with amyotrophic lateral sclerosis based on the observational study: a systematic review and meta-analysis.

Objective: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder affecting the upper and lower motor neurons. Though the pathogenesis of ALS is still unclear, exploring the associations between risk factors and ALS can provide reliable evidence to find the pathogenesis. This meta-analysis aims to synthesize all related risk factors of ALS to understand this disease comprehensively.

Telemedicine Adoption in an NCI-Designated Cancer Center During the COVID-19 Pandemic: A Report on Patient Experience of Care.

Background: Patients with cancer require timely access to care so that healthcare providers can prepare an optimal treatment plan with significant implications for quality of life and mortality. The COVID-19 pandemic spurred rapid adoption of telemedicine in oncology, but study of patient experience of care with telemedicine in this population has been limited. We assessed overall patient experience of care with telemedicine at an NCI-designated Comprehensive Cancer Center during the COVID-19 pandemic and examined changes in patient experience over time.

Fucosylation of HLA-DRB1 regulates CD4 T cell-mediated anti-melanoma immunity and enhances immunotherapy efficacy.

Immunotherapy efficacy is limited in melanoma, and combinations of immunotherapies with other modalities have yielded limited improvements but also adverse events requiring cessation of treatment. In addition to ineffective patient stratification, efficacy is impaired by paucity of intratumoral immune cells (itICs); thus, effective strategies to safely increase itICs are needed. We report that dietary administration of L-fucose induces fucosylation and cell surface enrichment of the major histocompatibility complex (MHC)-II protein HLA-DRB1 in melanoma cells, triggering CD4 T cell-mediated increases in itICs and anti-tumor immunity, enhancing immune checkpoint blockade responses.

A subnetwork-based framework for prioritizing and evaluating prognostic gene modules from cancer transcriptome data.

Cancer prognosis prediction is critical to the clinical decision-making process. Currently, the high availability of transcriptome datasets allows us to extract the gene modules with promising prognostic values. However, the biomarker identification is greatly challenged by tumor and patient heterogeneity.

The Impact of the Affordable Care Act on Insurance Coverage and Stage Among Head and Neck Squamous Cell Carcinoma Patients.

The purpose was to examine the change in percent uninsured and if there is change in T-stage, N-stage and overall-stage among nonelderly patients with newly diagnosed head and neck squamous cell carcinoma after the Affordable Care Act (ACA). The National Cancer Database was used for this study. Patients were divided between pre-ACA and post-ACA implementation with stratification between areas of ACA expansion versus non-expansion.

Prognostic features of endometrial cancer metastasis to the central nervous system.

Objectives: Central nervous system metastases (CNSm) secondary to endometrial cancer (EC) are rare. As a result, prognostic factors for this patient population are not well described.

Methods: EC patients with CNSm were identified retrospectively from two academic centers.

Transcriptomic analysis reveal the responses of dendritic cells to VDBP.

Background: Vitamin D binding protein (VDBP) is an essential plasma carrier protein, which plays possible roles in reproductive health, disease and so on. However, the effects of VDBP on immunity have not been fully studied and the pertinent literatures remain very limited.

Objective: In this study, we introduced the exogenous VDBP into DC2.