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

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ClinicalTrials.gov Identifier: NCT02951559
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Perri, University of Turin, Italy

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.


Condition or disease Intervention/treatment Phase
Encephalopathy HIV-encephalopathy Alzheimer Dementia Device: Nasal Brushing Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies
Study Start Date : March 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Brushing
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.




Primary Outcome Measures :
  1. Diagnostic concordance with gold standard diagnostic procedures [ Time Frame: Single-visit ]
    Positive and negative predictive values and correct classification rates of OM tests versus gold standard diagnostic procedures


Secondary Outcome Measures :
  1. Side effects of the nasal brushing [ Time Frame: Up to 6 months after the procedure ]
    Prevalence of side effects reported during the brushing and up to 6 months afterwards

  2. Cytological and immunohistochemistry examination of nasal brushing smear (neuronal abnormalities and expression of specific markers according to the different aetiologies) [ Time Frame: single-visit ]
    Prevalence of samples showing: abnormalities in cytological examination, antiOMP (Olfactory Marker Protein) positive cells, white blood cells and subtypes.

  3. OM markers of neuronal damage and amyloid deposition [ Time Frame: single-visit ]
    Quantification of tau, p-tau, 1-42 beta amyloid, S100beta, alpha synuclein, TDP-43 (TAR DNA-binding protein 43) on cell blocks and supernatant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951559


Contacts
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Contact: ANDREA CALCAGNO, MD, DTM&H +390114393884 andrea.calcagno@unito.it

Locations
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Italy
University of Torino Recruiting
Torino, Italy
Contact: Andrea Calcagno, MD    +390114393884    andrea.calcagno@unito.it   
Sub-Investigator: Stefano Bonora, MD         
Principal Investigator: Giovanni Di Perri, MD, PhD         
Sub-Investigator: Andrea Calcagno, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: GIOVANNI DI PERRI, MD, PhD University of Torino

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Responsible Party: Giovanni Di Perri, Professor of Infectious Diseases, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02951559     History of Changes
Other Study ID Numbers: SOLFAMU
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Brain Diseases
Alzheimer Disease
AIDS Dementia Complex
Central Nervous System Diseases
Nervous System Diseases
Dementia
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases