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Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis (GAMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259282
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment
Sarcoidosis Biological: Analysis of gamma globulin

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.

Study Design
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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : March 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Groups and Cohorts
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Intervention Details:
  • Biological: Analysis of gamma globulin
    Electrophoresis of proteins

Outcome Measures
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Primary Outcome Measures :
  1. Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity [ Time Frame: Day 1 ]
    Electrophoresis rates of serum proteins

  2. Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease [ Time Frame: Day 1 ]
    Electrophoresis rates of serum proteins


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with sarcoidosis
Criteria

Inclusion Criteria:

- Patients newly diagnosed with sarcoidosis

Exclusion Criteria:

  • Comorbidity responsible for a change in the level of gamma globulin
  • Other etiology of granulomatosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259282


Locations
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France
CHU de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03259282    
Other Study ID Numbers: 35RC16_3046_GAMES
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
gamma-Globulins
 Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs