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| Name | Class |
|---|---|
| Tampere University | OTHER |
| University of Oulu | OTHER |
| University of Turku | OTHER |
| University of Helsinki |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injecting drug induced histiocytosis | No intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitotriosidase | Diagnostic Test | The amount of patients with increased chitotriosidase, and the extent of elevation of chitotriosidase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of disease manifestations | To describe phenotype | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of elevated chitotriosidase activity | Is chitotriosidase activity associated with polyvinylpyrrolidone histiocytosis | 10 years |
| Mortality | Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitting to intravenous use of dissolved tablets (indicated for oral use) containing polyvinylpyrrolidone (PVP30) and positive tissue sample in any tissue biopsy compatible with features of histiocytosis caused by PVP30
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| Name | Affiliation | Role |
|---|---|---|
| Pasi I Nevalainen, MD, PhD | Senior consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Pirkanmaa | 33101 | Finland |
Study data can only be acquired by proper inquiry to the national authority Findata by law
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| ID | Term |
|---|---|
| D015614 | Histiocytosis |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008856 | Microscopy, Fluorescence |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
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Blood samples for RNA analyses (transcriptomics) Coded patient tissue biopsies containing histiocytosis Healthy tissue and other histiocytosis tissues from biobank(s) serve as controls
| Mass spectrometry | Diagnostic Test | to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls |
|
| scanning electron microscope with energy-dispersive X-ray spectroscopy | Diagnostic Test | to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls |
|
| Fluorescence microscopy | Diagnostic Test | to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls |
|
| Transcriptomics | Diagnostic Test | To describe pathologic signals of polyvinylpyrrolidone-exposed in vitro histiocytes of injecting drug users compared to control samples |
|
| 10 years |
| Microscopic fluorescence positive tissue | Search for specific polyvinylpyrrolidone fluorescence signal | 10 years |
| Scanning electron microscope with energy-dispersive X-ray spectroscopy | search for specific polyvinylpyrrolidone signal within cells | 10 years |
| Pyrolysis mass spectrometry | search for specific polyvinylpyrrolidone signal within cells | 10 years |
| Transcriptomics analysis | Search for immunologic pathway-specific abnormalities to guide treatment in cases compared with controls | 10 years |
| D008919 |
| Investigative Techniques |