Clinical Research Directory

Predictive Score in Patients With Hematological Malignancies Colonized by Multidrug-resistant Enterobacteriaceae

The goals of this observational study are to identify risk factors for ESBL-producing Enterobacterales and carbapenemase-producing Enterobacterales (CPE) colonization in oncohematological patients with severe neutropenia, and to develop and validate a predictive model of infection caused by ESBL-producing Enterobacterales and CPE in patients previously colonized by the same bacteria. The main questions the study aims to answer are: * What are the risk factors for ESBL-producing Enterobacterales and CPE colonization in patients with severe neutropenia? * Can a predictive model be developed to accurately predict infections in the colonized patients? Study Design \& Participants: Participants will be screened after receiving neutropenia-inducing treatment (e.g., chemotherapy, chimeric antigen receptor T-cell (CAR-T) therapy, or others). A baseline rectal swab will be collected to assess initial colonization status, followed by weekly swabs throughout the duration of neutropenia. Patients will be followed for 90 days from initial screening, during which the study team will record any infections, with an additional 30-day follow-up period. All hospitalization data will be recorded.

G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.

LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study)

Childhood cancer survivors represent a high-risk population that requires risk-based follow-up. Follow-up recommendations have been harmonized. Education and information practices regarding follow-up recommendations should be personalized, to ensure understanding by all survivors, including those with neurocognitive disorders. Individualized follow-up is necessary to detect complications that may increase morbidity and decrease quality of life, or even increase the risk of early mortality. In France, the LOG-AFTER software was developed in 2017 by university hospital of Angers and Epiconcept (approved health data host). The main differences with the European procedure concern radiotherapy information, the link with the General practitioner (GP), and the possible addition of information and/or access to therapeutic education in a video format. Indeed, there is the possibility of creating an GP account allowing to receive notifications concerning the follow-up of his patient to be scheduled, to have access to his file summary and his personalized follow-up plan, various information and blank prescription models. LOG-I is a study of the impact of the LOG-AFTER software for the "patient/GP" couple on adherence to follow-up recommendations. LOG-I is interested in all former patients with at least 3 recommendations in their personalized follow-up plan, taking into account the specific population of patients cured of a brain tumor.