Monitoring Risks for Hematological Changes in Gas Station Workers
Hematologic DiseasesGas station workers are exposed to carcinogenic substances.This increases risk of their exposure to hematological diseases such as lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), myelodysplastic syndromes (MDS), and myelogenous leukemia (AML), as well as different forms of non-Hodgkin's lymphoma (NHL) and multiple myeloma. Thus, the early identification of this condition between the gas station workers may prevent the hematological disease progression.
Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting
Blood DyscrasiaThis study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail...
Hematologic DiseaseNeoplams3 moreThe analysis of a cohort of consecutive non-selected patients from the Strasbourg University Hospital, and therefore representative of the real life, will allow better identifying the risk factors for these infections (by comparison with a cohort of patient with similar conditions of immunosuppression and no infection) and improving the diagnosis and therapeutic management. The primary objective is to identify prognosis factors affecting survival in patients with opportunistic infections
National Project on Vaccines, COVID-19 and Frail Patients
COVID-19Solid Tumor3 moreThis is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.
Breakthrough Invasive Mold Infections Under Posaconazole Prophylaxis (BIMI)
Invasive Mold InfectionsBreakthrough Invasive Mold Infections2 moreInvasive mold infections (IMI) mainly affect patients with hematologic malignancies receiving intensive chemotherapy or after hematopoietic stem cell transplantation (HSCT). Prolonged neutropenia after remission induction chemotherapy (>10 days duration) and continuous immunosuppression in the context of prevention or therapy of graft versus host disease (GVHD) for HSCT recipients (first 100 days post-transplantation and thereafter if GVHD is present) are considered as periods at high risk of IMI. Posaconazole prophylaxis is prescribed according to current guidelines to reduce the occurrence of IMI. Nevertheless, breakthrough IMI (bIMI), i.e. IMI occurring under mold-active prophylaxis, are still observed. The investigators hypothesized that the epidemiology of bIMI (under posaconazole prophylaxis) differs from that of IMI occurring in the absence of mold-active antifungal prophylaxis. Because bIMI are rare events since the introduction of posaconazole prophylaxis, epidemiological data of bIMI are scarce. This study aims to i) describe the epidemiology, clinical features, treatment and outcome of bIMI, ii) assess the causes of bIMI, iii) determine potential risk factors associated with the developllement of bIMI iv) assess the impact of bIMI on overall mortality. Design Retrospective and prospective, observational, case-control, multicenter, international study. The retrospective part will enroll previously identified bIMI cases and control cases (1:2) over the last five years: October 1st 2015 to September 30st 2020. The prospective part will enroll bIMI cases and control cases (1:2) occurring over a two-year period: October 1st 2020 to September 30st 2022. Setting The aim is to enroll 10 to 15 European centers with dedicated units for hematologic cancer patients. Currently, six centers have confirmed their participation (from Switzerland and Germany). Study Population Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis during induction, consolidation or re-induction chemotherapy or after HSCT. Cases : patients receiving posaconazole prophylaxis for at least 7 days and diagnosed with bIMI proven or probable according to EORTC-MSGERC. Controls: patients receiving posaconazole prophylaxis for at least 7 days, without diagnosis of bIMI possible, probable or proven according to EORTC-MSGERC. The objective is to enroll about 100 bIMI cases and 200 controls.
Prospective and Retrospective Cohort Study to Find New Prognostic Factors and Therapeutic Targets...
Malignant Hematologic DisorderThe purpose of this study is to elucidate the factors which are associated with the diagnosis and predict prognosis and therapeutic targets by collecting specimens of tissue sample, peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in patients with malignant hematologic disorders except acute leukemia. This study is eligible for patients who are diagnosed with malignant hematologic disorders except acute leukemia or who will have diagnostic procedure with suspicion of having hematologic malignancy. Prospective cohort is for patients who are not in treatment for hematologic malignancy. Retrospective cohort is for patients who are diagnosed and in treatment.
Registry of Febrile Neutropenia and Invasive Fungal Infections
Hematological DiseaseFebrile Neutropenia1 moreObjectives: To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy To explore the percentage/distribution of infectious origins of febrile neutropenia To explore the percentage/distribution of infectious pathogens of febrile neutropenia To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes
Assessing the Effect of Contact Isolation on Nosocomial Colonization With ESBL-EC in German Hematology/Oncology...
Oncology [See AlsoAffected System]2 moreThis study aims to evaluate the impact of contact isolation on the rate of hospital-acquired transmissions of ESBL-producing Escherichia coli (ESBL-EC) and the rate of colonization and infection. On the basis of this study, it will be possible to re-evaluate the need for contact isolation for patients colonized or infected with ESBL-EC.
Secure Outsourcing of Carfilzomib in the Treatment of Multiple Myeloma to the Hospital at Home Setting...
Hematological DiseasesSince 2009, the Department of Clinical Haematology at Limoges University Hospital Centre, supported by the HEMATOLIM network, has been operating the regional "ESCADHEM" system: [Secure outsourcing of injectable chemotherapy to the home care setting for malignant blood diseases]. In addition to Limoges University Hospital, Brive Hospital and Guéret Hospital, this system involves four Hospital at Home (HAH) structures across the three départements of the former Limousin region. In this process, chemotherapy administered by subcutaneous injection is prescribed by a hospital physician in one of the hospitals "authorised to deliver cancer treatments" in the former region of Limousin: Limoges University Hospital Centre, Brive Hospital or Guéret Hospital. This chemotherapy is then prepared in one of the three hospital pharmacies authorised to perform centralised reconstitution, in accordance with current standards. The preparation is then transferred to one of the four Hospital at Home (HAH) structures, which transports the product to the patient's home where it is administered by the nurse (IDE). This last step in the process is under the responsibility of the HAH structure coordinating physician, who is also responsible for waste collection. Supported by its experience within the ESCADHEM system with subcutaneous drugs and in the context of the arrival of new intravenous drugs, in short infusion form, the Department of Clinical Haematology, supported by the HEMATOLIM network (which became the HEMATOLIM association on 1 January 2020) and the professionals involved began the process of outsourcing these drugs to the HAH setting. One of these drugs is carfilzomib, used to treat multiple myeloma, and its outsourcing to the HAH setting was put in place from the end of 2018. In parallel with this, the Department of Clinical Haematology would like to set up a study to evaluate the feasibility of outsourcing this new drug, administered intravenously, based on a model that we know to be operational and secure for chemotherapies administered by subcutaneous injection. the Department of Clinical Haematology hope to be able to confirm the value of caring for multiple myeloma patients in an HAH setting by improving their quality of life and optimising their care pathway in organisational and economic terms. the Department of Clinical Haematology hope to be able to demonstrate that this organisation is not only efficient in the view of patients, but also for the healthcare professionals working in the Hospital, the HAH structure and in the community, involved throughout the care process. To conduct our study, the Department of Clinical Haematology selected the novel drug carfilzomib, used in the treatment of multiple myeloma. The prescribing conditions, treatment administration regimen and outsourcing quality processes for this drug are available in the annexes. These standard regimens were constructed on the basis of the protocols in the ESCADHEM system, extensively trialled and validated by the HAS, for drugs injected subcutaneously and following a collegial approach. We thus hope to demonstrate that the protocols used for drugs administered by subcutaneous injection - in particular, bortezomib and azacytidine - are applicable to carfilzomib following minor modifications to the procedures given the IV administration of the latter drug as a short infusion. It should be noted that it is essential that the first cycle of carfilzomib be administered, in its entirety, in an outpatient clinic setting. Thereafter, if the patient is eligible for treatment in an HAH setting, the 1st day of each cycle will be performed in an outpatient clinic. Following this study, the Department of Clinical Haematology hope to be able to publish our research and promote it at national and/or international congresses. This research should further reinforce our already significant experience in this type of care strategy for malignant blood diseases in the HAH setting, which we believe is simultaneously innovative, practical and beneficial for all the players in the care pathway concerned. The model will probably be useful for outsourcing to the HAH setting other novel drugs progressively arriving on the market with profiles similar to that of the drug we wish to study. Finally, our project aims to demonstrate that our procedures for the secure outsourcing of carfilzomib to the HAH setting, in place since the end of 2018 are valid and could be extended to other regions of France. Furthermore, the current health landscape is undergoing profound changes associated with budget constraints, as well as societal and technological evolutions, with the result that home care, and hence HAH structures, appear, more than ever, to be the model of the future.
Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Hematological DiseasesInvasive AspergillosisEvaluation of incidence of invasive aspergillosis in patients who have undergone an allogeneic stem cell transplantation, with particular regard to the role of galactomannan assay and of early TC scan in asymptomatic patients.