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CompletedNCT03259282GAMESUpdated Apr 12, 2018

Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis

An observational study in Sarcoidosis, sponsored by Rennes University Hospital. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
78
Sex
All
01

Study summary

Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in a retrospective cohort of patients at Rennes University Hospital

Read the detailed description

In 50% of cases, sarcoidosis is associated with polyclonal hypergammaglobulinemia. The other forms have a normal gamma globulin level.

The level of gamma globulinemia has not yet been studied as an evolutionary predictive factor. Furthermore, there are disseminated granulomatoses sharing common characteristics with sarcoidosis, associated with Common Variable Immunodeficiency deficit (DICV) type Primary Immunodeficiency syndrome (DIP), thus occurring in hypogammaglobulinemic patients.

02

Conditions studied

  • Sarcoidosis

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with sarcoidosis

Inclusion criteria

  • Patients newly diagnosed with sarcoidosis

Exclusion criteria

Exclusion Criteria:

  • Comorbidity responsible for a change in the level of gamma globulin
  • Other etiology of granulomatosis
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
78 participants (actual)
Patient registry
No

Interventions

  • BiologicalAnalysis of gamma globulin

    Electrophoresis of proteins

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What researchers measure

Primary outcomes

  1. Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity

    Electrophoresis rates of serum proteins

    Time frame: Day 1

  2. Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease

    Electrophoresis rates of serum proteins

    Time frame: Day 1

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Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03259282
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
Mar 7, 2017
Primary completion
Mar 22, 2017
Completion
Mar 22, 2017
Last update
Apr 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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