NCT04911348

Brief Summary

Neurosarcoidosis represents up to 10% of sarcoidosis cases. Little is known about its long-term course, even if the disease remains mainly monophasic with/w.o. sequelae, or if bouts of new symptoms may arise over years (polyphasic). Using retrospective data from patients diagnosed with neurosarcoidosis in three French referral centers for neuro-inflammation, the investigators aim to determine patterns of disease course, according to the initial presentation and the treatments used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 18, 2021

Last Update Submit

May 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in disease characteristics from Baseline to end of study

    composite variable with three categories : monophasic course / polyphasic course with the same symptoms / polyphasic course with different symptoms This variable is composite and its evaluated by the investigators by reviewing the medical file with every available document : MRI results, clinical evaluation

    from baseline to end of study (an average of 6 years)

Interventions

no intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every patient of the three centers meeting the inclusion criteria

You may qualify if:

  • To have at least one documented visit in one of the three referral neurological centers (Nancy, Bordeaux, Strasbourg) between Jan-1st-2000 and Jan-1st-2021
  • To be diagnosed with possible/probable/definite neurosarcoidosis

You may not qualify if:

  • \- Denial to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guillaume Mathey

Nancy, Lorraine, 54000, France

RECRUITING

MeSH Terms

Conditions

Neurosarcoidosis

Central Study Contacts

Guillaume Mathey, MD

CONTACT

Ines Bekkour, Student

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 18, 2021

First Posted

June 3, 2021

Study Start

June 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations