23 results match your criteria: "Epidemiology and Clinical Statistics for Tumor[Affiliation]"

There is a growing need to evaluate of multiple competing drugs in phase II trials where the number of patients is often limited, and simultaneous assessment of both efficacy and toxicity is crucial. To avoid the waste of research resources, it is indeed more efficient to screen multiple drugs at once in a platform phase II setting. We aim to adapt the Bayesian optimal phase II (BOP2) design to multi-arm trials for both uncontrolled and controlled settings.

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Article Synopsis
  • The study refines the prediction of outcomes in T-cell acute lymphoblastic leukemia (T-ALL) using next-generation sequencing (NGS) to identify genetic mutations associated with risk levels.
  • A classifier developed through whole-exome sequencing categorized patients into low-risk and high-risk groups based on specific mutations, revealing significant differences in their 5-year cumulative incidence of relapse (CIR).
  • Integrating this genetic stratification with clinical factors like white blood cell counts and minimal residual disease enhances prognosis and identifies potential patients for targeted therapies.
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What clinicians should know about surrogate end points in hematologic malignancies.

Blood

July 2024

Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments Team, INSERM, U1153, Assistance Publique-Hôpitaux de Paris Hôpital St Louis, Université Paris Cité, Paris, France.

Article Synopsis
  • - Surrogates are frequently used as primary endpoints in hematology/oncology clinical trials because they can be measured early and reflect the treatment's true effectiveness, such as overall survival.
  • - The text analyzes the quality of evidence for common endpoints in hematology and offers guidance on how to effectively implement and assess surrogate endpoints in research and clinical settings.
  • - The authors aim to make complex statistical concepts accessible for clinicians, fostering better collaboration between healthcare providers and experts in surrogacy.
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[Salivary gland neoplasms].

Rev Prat

September 2023

Service d'ORL, hôpital Lariboisière, AP-HP, Centre of Research in Epidemiology and Statistics (CRESS), UMR 1153, Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments (ECSTRRA), université Paris-Cité, Paris, France.

SALIVARY GLAND NEOPLASMS. Salivary gland tumors represent a heterogeneous group of lesions, with various anatomical locations. The most frequent site of involvement is the parotid, and the most frequent histology is pleomorphic adenoma, a benign tumor with the potential for recurrence and malignant transformation.

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Enriching single-arm clinical trials with external controls: possibilities and pitfalls.

Blood Adv

October 2023

Biostatistical Department, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.

For the past decade, it has become commonplace to provide rapid answers and early patient access to innovative treatments in the absence of randomized clinical trials (RCT), with benefits estimated from single-arm trials. This trend is important in oncology, notably when assessing new targeted therapies. Some of those uncontrolled trials further include an external/synthetic control group as an innovative way to provide an indirect comparison with a pertinent control group.

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Feasibility and Safety of Active Physiotherapy in the Intensive Care Unit for Intubated Patients with Malignancy.

J Rehabil Med

February 2023

Medical intensive care unit APHP Saint Louis, 1 avenue Claude Vellefaux Paris, France.

Objectives: Physiotherapy leads to improvements in critically ill patients who receive mechanical ventilation. However, cancer patients have not been included in previous studies on this subject. This study explored the feasibility and safety of physiotherapy in the intensive care unit for patients with malignancy.

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Tumor microenvironment exerts a critical role in sustaining homing, retention, and survival of chronic lymphocytic leukemia (CLL) cells in secondary lymphoid organs. Such conditions foster immune surveillance escape and resistance to therapies. The physiological microenvironment is rendered tumor permissive by an interplay of chemokines, chemokine receptors, and adhesion molecules as well as by direct interactions between malignant lymphocytes and stromal cells, T cells, and specialized macrophages referred to as nurselike cells (NLCs).

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Severe COVID-19 is associated with hyperactivation of the alternative complement pathway.

J Allergy Clin Immunol

February 2022

Department of Internal Medicine, National Reference Center for Rare Systemic Autoimmune Diseases, AP-HP Hôpital Cochin, Paris, France; Université de Paris, Paris Cardiovascular Center (PARCC), Inserm, Paris, France. Electronic address:

Article Synopsis
  • Severe COVID-19 is marked by impaired type I interferon activity and inflammation, with the complement system playing a crucial role in the inflammatory response.
  • The study examined RNA levels of 28 complement genes in COVID-19 patients compared to healthy controls, revealing different expression patterns linked to disease severity.
  • Findings suggest that the alternative complement pathway is significantly activated in severe cases, with implications for potential treatment strategies targeting this pathway.
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Diagnosis Yield and Safety of Surgical Biopsy in Interstitial Lung Diseases: A Prospective Study.

Ann Thorac Surg

November 2022

Pneumologie, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche-1272, Sorbonne Paris-Nord, Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Bobigny, France; Groupe Hospitalier Paris Saint Joseph, Paris, France.

Background: Surgical lung biopsy is essential in the diagnostic algorithm of interstitial lung disease (ILD) of unknown cause. Safety concerns have been recently reiterated. This study prospectively assessed the yield of diagnosis and safety of video-assisted thoracoscopic surgical lung biopsy (VATS-LB) for ILD diagnosis.

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Validation and Update of the Lémann Index to Measure Cumulative Structural Bowel Damage in Crohn's Disease.

Gastroenterology

September 2021

INSERM U1135 Centre de Recherche Epidémiologie et Statistiques, Equipe Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments, Université de Paris, Hôpital Saint-Louis, Paris, France.

Background & Aims: The Lémann Index is a tool measuring cumulative structural bowel damage in Crohn's disease (CD). We reported on its validation and updating.

Methods: This was an international, multicenter, prospective, cross-sectional observational study.

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Cancer Patients' Prehospital Emergency Care: Post Hoc Analysis from the French Prospective Multicenter Study EPICANCER.

J Clin Med

March 2021

Centre of Research in Epidemiology and StatisticS (CRESS), INSERM, UMR 1153, Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments (ECSTRRA) Team, University of Paris, 75006 Paris, France.

Background: Very little data are available concerning the prehospital emergency care of cancer patients. The objective of this study is to report the trajectories and outcomes of cancer patients attended by prehospital emergency services.

Methods: This was an ancillary study from a three-day cross-sectional prospective multicenter study in France.

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Harmonizing Heterogeneous Endpoints in Coronavirus Disease 2019 Trials Without Loss of Information.

Crit Care Med

January 2021

Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.

Objectives: Many trials investigate potential effects of treatments for coronavirus disease 2019. To provide sufficient information for all involveddecision-makers (clinicians, public health authorities, and drug regulatory agencies), a multiplicity of endpoints must be considered. The objectives are to provide hands-on statistical guidelines for harmonizing heterogeneous endpoints in coronavirus disease 2019 clinical trials.

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Background: The evaluation process of French medical students will evolve in the next few years in order to improve assessment validity. Script concordance testing (SCT) offers the possibility to assess medical knowledge alongside clinical reasoning under conditions of uncertainty. In this study, we aimed at comparing the SCT scores of a large cohort of undergraduate medical students, according to the experience level of the reference panel.

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Background: The clinical progress of patients hospitalized due to COVID-19 is often associated with severe pneumonia which may require intensive care, invasive ventilation, or extracorporeal membrane oxygenation (ECMO). The length of intensive care and the duration of these supportive therapies are clinically relevant outcomes. From the statistical perspective, these quantities are challenging to estimate due to episodes being time-dependent and potentially multiple, as well as being determined by the competing, terminal events of discharge alive and death.

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Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol.

Front Med (Lausanne)

June 2020

General Intensive Care Unit-Assistance Publique Hôpitaux de Paris, Raymond Poincaré Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Inserm UMR 1173, Infection and Inflammation (2I), University of Versailles Saint-Quentin en Yvelines (UVSQ), Paris-Saclay University, Paris, France.

Article Synopsis
  • Severe respiratory distress from COVID-19 causes significant discomfort (dyspnea) in ICU patients, negatively impacting their prognosis and the need for mechanical ventilation.
  • Despite mechanical support, many patients still experience dyspnea, highlighting the need for innovative, non-drug management strategies.
  • This study aims to assess the effects of transcranial direct current stimulation (tDCS) on alleviating dyspnea in mechanically ventilated COVID-19 patients by comparing two types of stimulation (anodal and cathodal) against a placebo.
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EPICANCER-Cancer Patients Presenting to the Emergency Departments in France: A Prospective Nationwide Study.

J Clin Med

May 2020

Centre of Research in Epidemiology and StatisticS (CRESS), INSERM, UMR 1153, Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments (ECSTRRA) Team. University of Paris, 75010 Paris, France.

Background: We aimed to estimate the prevalence of cancer patients who presented to Emergency Departments (EDs), report their chief complaint and identify the predictors of 30-day all-cause mortality.

Patients And Methods: we undertook a prospective, cross-sectional study during three consecutive days in 138 EDs and performed a logistic regression to identify the predictors of 30-day mortality in hospitalized patients.

Results: A total of 1380 cancer patients were included.

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Typology of Published Randomized Controlled Trials Investigating Initial Ventilation Strategy in Critically Ill Patients With Acute Respiratory Failure: A Methodologic Review.

Chest

September 2020

Medical Intensive Care Unit, Saint-Louis Teaching Hospital, Paris, France; ECSTRRA team, Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments, UMR 1153 (Center of Research in Epidemiology and Biostatistics), INSERM, Paris Diderot University, Paris, France. Electronic address:

Background: Randomized controlled trials (RCTs) in patients with hypoxemic acute respiratory failure (ARF) often failed to show survival benefits and resulted in varying clinical end points.

Research Question: This methodologic review was conducted of published RCTs on ARF, with a careful attention to whether the study results were positive or negative.

Study Design And Methods: MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science were searched for published RCTs in adult patients with ARF between January 1995 and December 2019.

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Introduction: The benefit of reducing the time of antibiotic initiation in the emergency department (ED) for neutropenic patients is controversial and the research on the impact of antibiotic adherence to international guidelines in the ED is scarce. We aimed to investigate the effect of antibiotic timing and appropriateness on outcomes in patients with febrile neutropenia (FN) and to assess the performance of the MASCC risk-index to risk-stratify such patients in the ED.

Methods: We prospectively identified patients with FN who presented to our ED and assessed their Multinational Association of Supportive Care in Cancer (MASCC) risk-index.

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Direct admission to the intensive care unit from the emergency department and mortality in critically ill hematology patients.

Ann Intensive Care

October 2019

Centre de Recherche en Épidémiologie et Statistiques - Université de Paris (CRESS-INSERM-UMR1153), Epidemiology and Clinical Statistics for Tumor, Respiratory, and Resuscitation Assessments (ECSTRRA) Team, Paris, France.

Background: The aim of this study was to assess the benefit of direct ICU admission from the emergency department (ED) compared to admission from wards, in patients with hematological malignancies requiring critical care.

Methods: Post hoc analysis derived from a prospective, multicenter cohort study of 1011 critically ill adult patients with hematologic malignancies admitted to 17 ICU in Belgium and France from January 2010 to May 2011. The variable of interest was a direct ICU admission from the ED and the outcome was in-hospital mortality.

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Center Effects in Hospital Mortality of Critically Ill Patients With Hematologic Malignancies.

Crit Care Med

June 2019

Service de Biostatistique et Information Médicale, AP-HP Hôpital Saint Louis, Paris, France.

Objectives: We aimed to investigate center effects on hospital mortality of ICU patients with hematologic malignancies and to explore interactions between center and patients characteristics.

Design: Multicenter prospective cohort.

Setting: Seventeen ICUs across France and Belgium.

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Disruption in time projection and non-adherence to long-term therapies.

Patient Prefer Adherence

November 2018

Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.

Objective: Patients' non-adherence to medical prescriptions is a crucial issue in contemporary medicine because it can jeopardize care efficacy. Non-adherence is especially frequent in patients with chronic diseases. In this article, we propose that a particular condition, which we call disruption in time projection, is a cause of non-adherence to medication therapies in chronic diseases.

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