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Enrolling by Invitation

NCT Number: NCT06573671

Histiocytosis in Injecting Drug Users

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, Pirkanmaa, 33101, Finland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All identified adult patients in our records with a history of injecting drug use by dissolving tablets containing polyvinylpyrrolidone and (suspected) PVP-histiocytosis

Exclusion criteria

  • Other histiocytosis diagnosed by tissue samples and clinical information

Treatment and study plan

Chitotriosidase

Diagnostic Test

The amount of patients with increased chitotriosidase, and the extent of elevation of chitotriosidase

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

Primary outcomes

  1. Frequency of disease manifestations

    Time frame: 10 years

    To describe phenotype

Secondary outcomes

  1. Frequency of elevated chitotriosidase activity

    Time frame: 10 years

    Is chitotriosidase activity associated with polyvinylpyrrolidone histiocytosis

  2. Mortality

    Time frame: 10 years

    Mortality

  3. Microscopic fluorescence positive tissue

    Time frame: 10 years

    Search for specific polyvinylpyrrolidone fluorescence signal

  4. Scanning electron microscope with energy-dispersive X-ray spectroscopy

    Time frame: 10 years

    search for specific polyvinylpyrrolidone signal within cells

  5. Pyrolysis mass spectrometry

    Time frame: 10 years

    search for specific polyvinylpyrrolidone signal within cells

  6. Transcriptomics analysis

    Time frame: 10 years

    Search for immunologic pathway-specific abnormalities to guide treatment in cases compared with controls

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University
  • University of Helsinki
  • University of Oulu
  • University of Turku

Registry information

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 27, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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