Histiocytosis in Injecting Drug Users
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency of disease manifestations
研究概览
简要总结
The goal of this observational study is to describe a new disease condition of histiocytosis related to injecting drug use, its preconditions, symptoms, signs, findings, and prognosis in a detailed and systematic patient series in one referral center. The main question[s] it aims to answer are:
- to find specific histologic features in different tissues to help the differential diagnosis from other histiocytoses
- to describe the value of chitotriosidase activity to screen this condition
- to describe the value of various tissue biopsies in confirming the diagnosis
- to describe the nature of polyvinylpyrrolidone accumulation in tissue macrophages by novel special microscopic techniques
- to find new tandem mass spectrometry methodology to prove polyvinylpyrrolidone accumulation in macrophages
- to show that polyvinylpyrrolidone treatment activates macrophages to histiocytes and causes povidone accumulation within the cells in in vitro experiments
- to evaluate the pathology of macrophage activation to histiocytes by transcriptomics
The patient history will be collected from the data produced by follow-up of cases followed up in a single center. A subgroup of participants will be given an opportunity to sign informed consent to give access to/donate blood and tissue samples to search for techniques to prove polyvinylpyrrolidone storage within histiocytes, and to search for transcriptomics signal(s) in histiocytes.
Researchers will compare blood and tissue samples from the biobank as controls.
详细描述
Comprehensive patient data (disease history, findings, complications, laboratory findings, histopathology, and imaging) will be obtained from patient records of a single university hospital. Coded histiocytosis-positive tissue samples will be compared to biobank samples from corresponding tissues from healthy and other histiocytosis tissue samples to show polyvinylpyrrolidone storage with novel methodologies.
In addition, if a study participant who is followed up clinically, signs informed consent, monocytes are separated from a blood sample, differentiated to macrophages, and exposed to polyvinylpyrrolidone. Various novel methods will be utilized to explore polyvinylpyrrolidone within histiocytes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All identified adult patients in our records with a history of injecting drug use by dissolving tablets containing polyvinylpyrrolidone and (suspected) PVP-histiocytosis
排除标准
- •Other histiocytosis diagnosed by tissue samples and clinical information
结局指标
主要结局
Frequency of disease manifestations
时间窗: 10 years
To describe phenotype
次要结局
- Frequency of elevated chitotriosidase activity(10 years)
- Mortality(10 years)
- Microscopic fluorescence positive tissue(10 years)
- Scanning electron microscope with energy-dispersive X-ray spectroscopy(10 years)
- Pyrolysis mass spectrometry(10 years)
- Transcriptomics analysis(10 years)