A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of biological specimen collections
研究概览
简要总结
This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.
详细描述
CTCL is a heterogeneous group of non-Hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant T cells in the skin. In order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from CTCL patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations.
Scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. This type of information will thus be of great advantage to future patients with these diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy.
- •Patients with Sézary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μL Sézary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio ≥10; (3) CD4+cluster of differentiation 7 (CD7)- cells ≥40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells ≥30 percent.
- •Ability to understand and willing to sign a willing informed consent document.
- •Age ≥ 18 years.
- •Inclusion Criteria for Age and Sex Matched Controls:
- •Matched for sex, and age +/- 10 years.
- •Ability to sign informed consent document.
- •Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents.
排除标准
- •Patients with a history of previous lymphoma other than CTCL or SS or LYP.
- •Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.
- •Current, viable pregnancy.
- •Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months.
- •Exclusion Criteria for Age and Sex Matched Controls:
- •Previous history of CTCL, SS, LYP, or any lymphoma.
- •Previous history of Human Immunodeficiency Virus (HIV) infection.
- •Anemia with a documented hemoglobin laboratory value of <7.5 g/dl within the past 6 months.
结局指标
主要结局
Number of biological specimen collections
时间窗: 2 years
This is a collection protocol to establish a tissue repository for samples from patients with CTCL.
次要结局
未报告次要终点