A Phase 4 interventional study of Nasal Brushing in Encephalopathy, HIV-encephalopathy and Alzheimer Dementia, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by University of Turin, Italy · Phase 4, Interventional, and Diagnostic
Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous etiology. Several causes have been recognized including neurodegenerative, vascular, infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders. While 30-50% of acute encephalitis remains without etiological definition, definitive criteria for neurodegenerative diseases are usually unavailable in vivo and possible or probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa that carries the specialized sensory organ for the modality of smell; the olfactory epithelium is composed of five principal cell types including olfactory receptor neurons. A sample of OM may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients, not-contraindicated in patients with raised intracranial pressure and associated with almost no side-effects. Nasal brushing has recently been proposed for the in vivo diagnosis of Creutzfeldt-Jakob disease (CJD).
Aims of the project are:
A prospective, case control, multicentric study enrolling 400 patients and 100 controls (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be diagnosed and followed according to international guidelines and local clinical practice. Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the diagnosis according to the clinical or radiological suspect.
502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.
This study's planned enrollment of 250 is above the median of 66 across 339 interventional studies indexed under Brain Diseases.
Browse Brain Diseases studies →University of Turin, Italy is the lead sponsor of 214 studies on the registry; 35 are open to participants now.
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Inclusion criteria for cases:
Inclusion criteria for controls:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo nasal brushing as further described additionally to other gold standard practices according to the suspected aetiology (brain MRI, lumbar puncture, plasma tests, etc.)
Device: Nasal Brushing
Nasal brushing will be performed in non-sedated patients as follows. After administration of a local vasoconstrictor (1% epinephrine) with the use of a nasal tampon, inserted into the nasal cavity of the patient to locate the olfactory mucosa lining the nasal vault. A sterile, disposable brush ("Copanflock", "Copan", Brescia, Italy) will be inserted gently rolled on the mucosal surface, withdrawn,and immersed in 0.9% saline solution, UTM (Universal Transporter Medium) or 4% formaldehyde. Two swabs will be collected for each nostril.
Diagnostic concordance with gold standard diagnostic procedures
Positive and negative predictive values and correct classification rates of OM tests versus gold standard diagnostic procedures
Time frame: Single-visit
Side effects of the nasal brushing
Prevalence of side effects reported during the brushing and up to 6 months afterwards
Time frame: Up to 6 months after the procedure
Cytological and immunohistochemistry examination of nasal brushing smear (neuronal abnormalities and expression of specific markers according to the different aetiologies)
Prevalence of samples showing: abnormalities in cytological examination, antiOMP (Olfactory Marker Protein) positive cells, white blood cells and subtypes.
Time frame: single-visit
OM markers of neuronal damage and amyloid deposition
Quantification of tau, p-tau, 1-42 beta amyloid, S100beta, alpha synuclein, TDP-43 (TAR DNA-binding protein 43) on cell blocks and supernatant
Time frame: single-visit
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2016, a primary completion of Feb 2023 and a completion of Feb 2023. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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