Collecte d'échantillons de tissu pour les malignités lymphoïdes et leurs précurseurs
Cette étude vise à collecter et observer des échantillons de tissus provenant de personnes atteintes de malignités lymphoïdes et de leurs précurseurs afin d'explorer des informations biologiques.
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveTroubles des Protéines Sanguines+23
+ Maladies Cardiovasculaires
+ Maladies Hématologiques
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 21 septembre 2012
Date à laquelle le premier participant a commencé l'étude.Background: -An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin's lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre-malignant conditions. Objectives: -This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models. Eligibility: -Adult patients who meet one of the following: * Confirmed pathological diagnosis of lymphoid malignancy or lymphoid precursor, including B-cell and T-cell lymphomas: including but not limited to diffuse large Bcell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL). * No known lymphoid malignancy or lymphoid precursor diagnosis and planning a surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/malignancy) may be obtained for research studies as part of this protocol. Design: * The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of lymphoid malignancies. * It is anticipated that up to 60 consented subjects will be studied each year. To account for these anticipated 60 consented subjects in addition to up to potentially 5 screen fails each year an accrual ceiling of 650 consented subjects was initially planned over the first 10 years of study. To account for additional consented subjects after the first 10 years of study in addition to samples transferred from other studies, the total accrual ceiling has been increased to 1,292 subjects.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.1295 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
* LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients with a known lymphoid malignancy or precursor disease, as described: INCLUSION CRITERIA: * Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL). * Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis. * Age \>= 18 years of age * Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study. EXCLUSION CRITERIA: * Pregnant individuals will not be eligible. * Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, and/or pulmonary dysfunction. * Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator. NON-LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described: INCLUSION CRITERIA: -Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/ malignancy) may be obtained for research studies as part of this protocol. Patient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery. * Age \>= 18 years of age * Must be able and willing to sign informed consent EXCLUSION CRITERIA: * Pregnant individuals will not be eligible. * Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for \>=2 years will also be eligible at the discretion of the investigator. * Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
National Institutes of Health Clinical Center
Bethesda, United StatesOuvrir National Institutes of Health Clinical Center dans Google MapsUniversity of the West Indies
Kingston, Jamaica