Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care

NCT07280871 | Not Yet Recruiting

• 1 other identifier: LUX-CLIN-03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data. This program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses. By combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression. Although many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Clinically Isolated Syndrome; Primary Progressive Multiple Sclerosis

Keywords

AI; Machine Learning; MS; phenotyping; personalised medicine

Outcome Measures

Primary Outcomes (1)

• Identification of Clinical, Imaging, and Omics Signatures for MS Subtype Stratification

  Identify clinical, epidemiological, imaging and omics characteristics associated with changes of status for different subtypes of MS patients allowing the stratification of these patients according to similar patterns and disease courses.The primary endpoint will be the change of status of the patients' disease between the baseline and at Year 1. The status of the disease will be determined by using the No Evidence of Disease Activity (NEDA MS- 3).

  1 year

Secondary Outcomes (1)

• Building Resources and Digital Tools to Advance Research and Healthcare in Multiple Sclerosis

  1 year

Other Outcomes (1)

• Unraveling Molecular, Cellular, and Clinical Determinants of MS Activity and Progression"

  5 years

Study Arms (1)

Single Arm Study

Patients with MS

Other: Cohort

Interventions

Cohort OTHER

Participants will provide data and samples for analysis. In the first year after inclusion, demographics, lifestyle, labs, and physical exams will be collected at baseline, 6, and 12 months. Patient-Reported Outcomes (PROs) and challenges will be gathered between visits via the dreaMS app. Biological samples (blood required; saliva, urine, stool, CSF, hair optional), tissue from endoscopic biopsy, and imaging (if done as standard care) will be taken at baseline, 6, and 12 months. One unscheduled visit may occur for flares or treatment changes. From month 12 to 4 years later, yearly medical data, PROs every 6 months, and continuous smartwatch data will be collected.

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS as follows: Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (\< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.

You may qualify if:

• Signed informed consent form
• ≥ 18 years of age
• Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.
• Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (\< 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.

You may not qualify if:

• Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.
• Not fluent in any of the following languages: French, English or German.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Centre Hospitalier du Luxembourg: collaborator
• Luxembourg National Research Fund: collaborator

Study Sites (1)

Centre Hospitalier de Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Related Links

• Webpage to gather information on the Clinnova programme; Clinnova: a precision health initiative in the heart of Europe

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine, saliva, hair, archiving tissue samples from Standard Of care biopsy; Cerebrospinal fluid left-over from from Standard Of care procedures

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Krüger Rejko, Prof. Dr. MD

  LIH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmin Schulz, PhD

CONTACT

352 26970-265; Jasmin.Schulz@lih.lu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2040
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)