IPPEMAssociation Between Proton Pump Inhibitors and the Incidence of Hematologic Toxicity of Pemetrexed: a Prospective, Multicenter, Observational and Longitudinal Study Among Patients Treated by a Pemetrexed-based Chemotherapy
Colección de datos
Recopilados desde hoy en adelante - ProspectivoCarcinoma de pulmón no microcítico+7
+ Carcinoma broncogénico
+ Neoplasias bronquiales
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 2 de mayo de 2018
Fecha en la que se inscribió al primer participante.Prospective, longitudinal, multicenter and observational study. All eligible patients will receive clear information about aims and research modalities on the medical consultation and before first course of chemotherapy. If patient agrees with study aims and protocol, disease and therapeutic management will not be change. Research agree and participation leads to Data collection: * Clinical data: weight, height, body mass index 1. Demographic data: sociodemographic data, comorbidities 2. Disease data: related to tumor disease and antineoplastic protocol including adjuvant medications like antiemetic of antidiarrheal agents for example. * complete medication review: a minimum of 3 information sources among the patient and/or family and close, patient health records, community pharmacy, general practitioner, * activation of a specific study patient record * biologic data collection: blood count and thrombocythemia during all period study and three week after patient study completion, * supplementary data in case of hematologic toxicity: hospitalization, growth factors (like erythropoietin and/or granulocyte colony-stimulating factor use), blood transfusions, intravenous iron, chemotherapy treatment delay All patients are followed since inclusion and for 18 months. Research logistic Patients will be recruited in cancer hospital service where patients received pemetrexed in the four study participant centers. Full information and all necessary clarification about study will be explained to all eligible patients with an appropriate consent form. Data collection using case report form will be performed by pharmacists and physicians from hospitalization setting. Recruiting duration period Twelve months Subject duration period Eighteen months Subject accessibility Patients will be recruited in one of the four participant centers Statistical analysis Number of patients to include with statistical considerations It is planned to include 100 patients per group after calculating the number of subjects required (nQuery software) taking into account the following assumptions: * Risk alpha = 0.05 * Statistical power = 90% * Percentage of patients without hematologic toxicity in PPI-negative group = 0.62 * Percentage of patients without hematologic toxicity in PPI-positive group = 0.88 (Hazard ratio = 3.74) Statistical analysis methods of criteria Data description will be performed using mean and standard deviation or median (interquartile interval and minimum and maximum) for quantitative variables according to variable distribution and number and percentage for qualitative variables. Bivariate analysis will be conducted in order to found the association between hematological toxicity or not and clinical variables. Multivariate analysis will be performed with Cox model, using a dependent variable "presence or not of a hematologic toxicity" and independents variables, variables that are associated with a "p" less than 0.20 with confusion factors adjustment. Treatment of missing data The study will be performed in order to minimize the number of missing data. For each variable number and percentage of missing data will be described.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 172 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación