Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades hemáticas y linfáticas+7
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
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: 7 de junio de 1997
Fecha en la que se inscribió al primer participante.Background: The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years. Blood obtained by apheresis or blood drawing, skin biopsies and other tissues will be evaluated for abnormalities related to immunity, HTLV-1 infection and the immune system. Advances in the characterization of acquired genetic changes in tumor samples has led to insights for the development of targeted therapy of malignancy Objectives: To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer To define the nature of the immunological, genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections and/or a high incidence of malignancy and in patients with cancer. To obtain whole blood, plasma and leukocytes, as well as skin, lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system. Eligibility: Subjects with cancer. Subjects with immunodeficiency. Subjects with HTLV-1 infection. Design: -This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 902 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
INCLUSION CRITERIA: Participants must meet at least one of these criteria: Have suspected or known disorder of the immune system or cancer Be a known or potential carrier of autoimmune disorder or immunodeficiency disease. Specific disorders may include but are not limited to: X-linked (severe combined immunodeficiency) Autosomal recessive SCID X-linked CD40 ligand deficiency Common variable immunodeficiency Ataxia-telangiectasia Wiskott Aldrich syndrome DiGeorge syndrome Infection with HTLV-1 Age greater than or equal to 18 years. Participant must be able to understand and sign informed consent. Participants who will undergo apheresis must have hematocrit greater than 28%, and platelet count greater than 50,000. Subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a Department of Transfusion Medicine consult physician. Weight greater than 25 kg is necessary for apheresis. EXCLUSION CRITERIA: Overall Exclusion Criteria: Pregnant women will not be eligible for any aspect of this protocol. Exclusion Criteria for Apheresis Alone: Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following: Congestive Heart Failure History of angina Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.) Poorly controlled hypertension (average baseline blood pressure greater than 160/90) History of a coagulation protein disorder. Pediatric patients (less than 18 years) will not undergo apheresis.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
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
National Institutes of Health Clinical Center
Bethesda, United StatesAbrir National Institutes of Health Clinical Center en Google Maps