New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of patients with diagnoses
研究概览
简要总结
Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD). Overcoming these delays and missed diagnoses requires new approaches to identify lymphoma and MCD.
详细描述
To address the need for new approaches to diagnose lymphoma and multicentric Castleman disease (MCD), investigators have developed an assay based on nucleic acid measurement that has the potential to be delivered at the point of clinical care. It has demonstrated the ability to detect Epstein-Barr virus (EBV) from fine needle aspirations (FNA) and from tumor cells using the Tiny Isothermal Nucleic acid Amplification System (TINY) device, employing primers for EBV-encoded small RNAs (EBER). The method takes advantage of the now well-established finding that Kaposi sarcoma herpesvirus (KSHV) is nearly entirely sensitive (though not specific) for the diagnosis of MCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥1 year old and body weight of ≥ 10 kg.
- •HIV-infected.
- •Unexplained lymphadenopathy with at least one lymph node ≥2 cm that is amenable to biopsy.
- •Willing and able to give informed consent if the subject is 18 years of age or older, adolescent assent and legal guardian consent for subjects 15-17 years of age, pediatric assent and legal guardian consent for subjects 7-14 years of age, or legal guardian consent for pediatric subjects less than 7 years of age.
排除标准
- •Cannot or is not willing to follow study procedures.
- •Subjects with a previous history of cancer in the last five years with the exception of subjects with Kaposi sarcoma (i.e. history of Kaposi sarcoma is allowed in the study).
研究组 & 干预措施
HIV-infected patients with unexplained lymphadenopathy
HIV-infected patients in routine clinical care with unexplained lymphadenopathy
干预措施: Lymph Node or Core Needle Biopsy (Procedure)
HIV-infected patients with unexplained lymphadenopathy
HIV-infected patients in routine clinical care with unexplained lymphadenopathy
干预措施: Fine Needle Aspiration (Procedure)
HIV-infected patients with unexplained lymphadenopathy
HIV-infected patients in routine clinical care with unexplained lymphadenopathy
干预措施: Tiny Isothermal Nucleic acid Amplification System (TINY) (Diagnostic Test)
结局指标
主要结局
Number of patients with diagnoses
时间窗: Enrollment
Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.
次要结局
- Baseline clinical and laboratory characteristics(Enrollment)
- Diagnostic performance of KSHV DNA quantification using TINY(Enrollment)
- Diagnostic performance of EBV DNA quantification using TINY(Enrollment)
- Performance of KSHV DNA quantification using TINY(Enrollment)
- Performance of EBV DNA quantification using TINY(Enrollment)
研究者
Matthew Painschab
Associate Professor of Medicine
Indiana University