the EXPOSITION Study

NCT ID: NCT06325358

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-12-30

Brief Summary

This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Environmental Exposure; Lifestyle Factors

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Subjects with Multiple sclerosis

Age ≥ 18 years

• Diagnosis of MS according to 2017 McDonald criteria
• Relapsing-remitting (RR) MS
• Residence in the provinces of Pavia or Milan (Italy)
• Informed consent form signed

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Diagnosis of MS according to 2017 McDonald criteria
• Relapsing-remitting course (RR)
• Routine clinical examinations scheduled in the study period September 15, 2023, to March 15, 2024,
• Residing in the provinces of Pavia and Milano
• Informed consent form signed

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Council (Consiglio Nazionale delle Ricerche)

UNKNOWN

Sponsor Role: collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eleonora Tavazzi

Role: PRINCIPAL_INVESTIGATOR

Neurological Institute-Foundation IRCCS Casimiro Mondino, Pavia, Italy

Locations

IRCCS Foundation C. Mondino

Pavia, , Italy

Countries

Italy

Central Contacts

Eleonora Tavazzi

Role: CONTACT

eleonora.tavazzi@mondino.it

0382380403 ext. +39

Hellas Cena

Role: CONTACT

hellas.cena@unipv.it

3357699199 ext. +39

Facility Contacts

Eleonora Tavazzi

Role: primary

eleonora.tavazzi@mondino.it

0382 380403 ext. +39

Other Identifiers

0040083/23

Identifier Type: -

Identifier Source: org_study_id