Clinical trial NCT02951559: SOLFAMU Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies
Official title: Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Encephalopathy
HIV-encephalopathy
Alzheimer Dementia
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diagnostic study
Primary purpose: DIAGNOSTIC

Brief summary: 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:

1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU) specialists in the technique of nasal brushing;
2. Conducting a prospective study comparing the use of nasal brushing with gold-standard criteria in the diagnosis of Encephalopathies;
3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies.

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.


Eligibility criteria: Inclusion criteria for cases:

* age\>18 years;
* signing a written informed consent (by the patients or his/her legal representant);
* clinical suspect of encephalopathy (acute or subacute) including acute encephalitis, neurodegenerative disorders and HIV-associated neurocognitive disorders.

Inclusion criteria for controls:

* age\>18 years;
* signing a written informed consent (by the patients or his/her legal representant); • clinical indication for rhinoscopy for stenotic disease of nasal sept or turbinates.

Exclusion criteria:

* Nasal anatomical abnormalities precluding the execution of nasal brushing;
* Serious general conditions and/or comorbidities in patients for whom nasal brushing may be a risk factor precipitating their pre-existing condition;
* Anti-coagulant treatment.

Primary outcomes:
measure: Diagnostic concordance with gold standard diagnostic procedures
timeFrame: Single-visit
Secondary outcomes:
measure: Side effects of the nasal brushing
timeFrame: Up to 6 months after the procedure
measure: Cytological and immunohistochemistry examination of nasal brushing smear (neuronal abnormalities and expression of specific markers according to the different aetiologies)
timeFrame: single-visit
measure: OM markers of neuronal damage and amyloid deposition
timeFrame: single-visit
Other outcomes:
Locations:
city: Torino
country: Italy
facility: University of Torino
Study officials:
affiliation: University of Torino
name: GIOVANNI DI PERRI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: