HistiocytosisNCT06573671
Histiocytosis in Injecting Drug Users
An observational study of Histiocytosis, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Histiocytosis
- What is being tested?
- Chitotriosidase, Mass spectrometry and scanning electron microscope with energy-dispersive X-ray spectroscopy
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 29 May 2023to 31 Dec 2030
- How long will I take part?
- 40 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- All identified adult patients in our records with a history of injecting drug use by dissolving tablets containing polyvinylpyrrolidone and (suspected) PVP-histiocytosis
Who cannot join
- Other histiocytosis diagnosed by tissue samples and clinical information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read more
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.
Read the 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.
- Conditions
- Histiocytosis
- Being tested
- Chitotriosidase, Mass spectrometry, scanning electron microscope with energy-dispersive X-ray spectroscopy, Fluorescence microscopy, Transcriptomics
- Keywords
- intravenous, drug abuse, polyvinylpyrrolidone, PVP
- Medical subject headings
- Histiocytosis, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitotriosidaseDiagnostic test
The amount of patients with increased chitotriosidase, and the extent of elevation of chitotriosidase
Mass spectrometryDiagnostic test
to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls
scanning electron microscope with energy-dispersive X-ray spectroscopyDiagnostic test
to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls
Fluorescence microscopyDiagnostic test
to show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls
TranscriptomicsDiagnostic test
To describe pathologic signals of polyvinylpyrrolidone-exposed in vitro histiocytes of injecting drug users compared to control samples
| Study group | Role | What they receive |
|---|---|---|
| Injecting drug induced histiocytosis | No intervention Receives: Diagnostic Test: Chitotriosidase; Diagnostic Test: Mass spectrometry; Diagnostic Test: scanning electron microscope with energy-dispersive X-ray spectroscopy; Diagnostic Test: Fluorescence microscopy; Diagnostic Test: Transcriptomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of disease manifestations
To describe phenotype
Measured: 10 years
Secondary outcomes (6)
Frequency of elevated chitotriosidase activity
Is chitotriosidase activity associated with polyvinylpyrrolidone histiocytosis
Measured: 10 years
Mortality
Mortality
Measured: 10 years
Microscopic fluorescence positive tissue
Search for specific polyvinylpyrrolidone fluorescence signal
Measured: 10 years
Scanning electron microscope with energy-dispersive X-ray spectroscopy
search for specific polyvinylpyrrolidone signal within cells
Measured: 10 years
Pyrolysis mass spectrometry
search for specific polyvinylpyrrolidone signal within cells
Measured: 10 years
Transcriptomics analysis
Search for immunologic pathway-specific abnormalities to guide treatment in cases compared with controls
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 May 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistiocytosisStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 40 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Oulu, University of Turku, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Pasi I Nevalainen, MD, PhD, Principal investigator, Senior consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573671
- Sponsor's protocol ID
- R20105
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data can only be acquired by proper inquiry to the national authority Findata by law
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histiocytosis in Injecting Drug Users
- ClinicalTrials.gov ID
- NCT06573671
- Acronym / sponsor ID
- R20105
- Conditions
- Histiocytosis
- Keywords
- intravenous, drug abuse, polyvinylpyrrolidone, PVP
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Oulu, University of Turku, University of Helsinki
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 40 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injecting drug induced histiocytosis | – | Diagnostic Test: Chitotriosidase, Diagnostic Test: Mass spectrometry, Diagnostic Test: scanning electron microscope with energy-dispersive X-ray spectroscopy, Diagnostic Test: Fluorescence microscopy, Diagnostic Test: TranscriptomicsNo intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- All identified adult patients in our records with a history of injecting drug use by dissolving tablets containing polyvinylpyrrolidone and (suspected) PVP-histiocytosis
Key exclusion criteria (1 listed)
- Other histiocytosis diagnosed by tissue samples and clinical information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitotriosidaseThe amount of patients with increased chitotriosidase, and the extent of elevation of chitotriosidase | Diagnostic test | Injecting drug induced histiocytosis |
| Mass spectrometryto show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls | Diagnostic test | Injecting drug induced histiocytosis |
| scanning electron microscope with energy-dispersive X-ray spectroscopyto show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls | Diagnostic test | Injecting drug induced histiocytosis |
| Fluorescence microscopyto show polyvinylpyrrolidone presence in histiocytes of injecting drug users compared to controls | Diagnostic test | Injecting drug induced histiocytosis |
| TranscriptomicsTo describe pathologic signals of polyvinylpyrrolidone-exposed in vitro histiocytes of injecting drug users compared to control samples | Diagnostic test | Injecting drug induced histiocytosis |
Primary outcome
Frequency of disease manifestations
Time frame: 10 years
To describe phenotype
6 secondary outcomes
Frequency of elevated chitotriosidase activity
Time frame: 10 years
Mortality
Time frame: 10 years
Microscopic fluorescence positive tissue
Time frame: 10 years
Scanning electron microscope with energy-dispersive X-ray spectroscopy
Time frame: 10 years
Pyrolysis mass spectrometry
Time frame: 10 years
Transcriptomics analysis
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No. Study data can only be acquired by proper inquiry to the national authority Findata by law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pasi I Nevalainen, MD, PhD principal investigator
Senior consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histiocytosis, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of disease manifestations (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.