SOLFAMU Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies

NCT02951559 | Unknown Phase 4

• 1 other identifier: SOLFAMU
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Encephalopathy; HIV-encephalopathy; Alzheimer Dementia

Outcome Measures

Primary Outcomes (1)

• Diagnostic concordance with gold standard diagnostic procedures

  Positive and negative predictive values and correct classification rates of OM tests versus gold standard diagnostic procedures

  Single-visit

Secondary Outcomes (3)

• Side effects of the nasal brushing

  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)

  single-visit

• OM markers of neuronal damage and amyloid deposition

  single-visit

Study Arms (1)

Brushing

EXPERIMENTAL

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

Interventions

Nasal Brushing DEVICE

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.

Brushing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Torino

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Brain Diseases; AIDS Dementia Complex; Alzheimer Disease

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• GIOVANNI DI PERRI, MD, PhD

  University of Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANDREA CALCAGNO, MD, DTM&H

CONTACT

+390114393884; andrea.calcagno@unito.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Infectious Diseases

Model Details: Diagnostic study

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)