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Histiocytosis in Injecting Drug Users

Histiocytosis in Injecting Drug Users

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06573671
Enrollment
30
Registered
2024-08-27
Start date
2023-05-29
Completion date
2030-12-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histiocytosis

Keywords

intravenous, drug abuse, polyvinylpyrrolidone, PVP

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTChitotriosidase

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

DIAGNOSTIC_TESTMass spectrometry

to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls

DIAGNOSTIC_TESTscanning electron microscope with energy-dispersive X-ray spectroscopy

to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls

DIAGNOSTIC_TESTFluorescence microscopy

to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls

DIAGNOSTIC_TESTTranscriptomics

To describe pathologic signals of polyvinylpyrrolidone-exposed in vitro histiocytes of injecting drug users compared to control samples

Sponsors

Tampere University
CollaboratorOTHER
University of Oulu
CollaboratorOTHER
University of Turku
CollaboratorOTHER
University of Helsinki
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of disease manifestations10 yearsTo describe phenotype

Secondary

MeasureTime frameDescription
Mortality10 yearsMortality
Microscopic fluorescence positive tissue10 yearsSearch for specific polyvinylpyrrolidone fluorescence signal
Frequency of elevated chitotriosidase activity10 yearsIs chitotriosidase activity associated with polyvinylpyrrolidone histiocytosis
Pyrolysis mass spectrometry10 yearssearch for specific polyvinylpyrrolidone signal within cells
Transcriptomics analysis10 yearsSearch for immunologic pathway-specific abnormalities to guide treatment in cases compared with controls
Scanning electron microscope with energy-dispersive X-ray spectroscopy10 yearssearch for specific polyvinylpyrrolidone signal within cells

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026