NCT05326048

Brief Summary

The objective of APOLLO is therefore to identify biomarkers associated with the CNS involvement phenotype in early MS patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 9, 2022

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences in Immune profile

    Comparison of immune profile by CyTOF between two groups of MS patients: "brain" versus "brain + ME" CITRUS algorithm will be used to perform a unsupervised hierarchical clustering of cells processed by cytof and SAM test to assess statistical differences in abundances or marker expression levels between groups of patients

    1 day

Interventions

cytof analysis of biological samples of CIS patients. Genomic analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CIS patients

You may qualify if:

  • Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
  • At least 18 years old
  • Diagnosed with MS according to the 2017 criteria at the time of their last visit
  • Not opposed to participating in the study
  • Had at least one visit in the year following sampling
  • Followed up for at least 1 year after collection.
  • Signed OFSEP consent form

You may not qualify if:

  • CIS patients with progressive MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 13, 2022

Study Start

March 9, 2022

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations