Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573671
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Histiocytosis in Injecting Drug Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Histiocytosis in Injecting Drug Users
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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 todonate blood and tissue samples to search for techniques to prove polyvinylpyrrolidone storage within histiocytes and to search for transcriptomics signals in histiocytes
Researchers will compare blood and tissue samples from the biobank as controls
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 todonate blood and tissue samples to search for techniques to prove polyvinylpyrrolidone storage within histiocytes and to search for transcriptomics signals in histiocytes
Researchers will compare blood and tissue samples from the biobank as controls
Detailed Description:
We will search for comprehensive patient data disease history findings complications laboratory findings histopathology and imaging 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 other histiocytosis tissue samples to show polyvinylpyrrolidone storage with novel methodologies
In addition if study participant who is followed up 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
In addition if study participant who is followed up 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None