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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

Tracking Information
First Submitted Date August 21, 2017
First Posted Date August 23, 2017
Last Update Posted Date April 12, 2018
Actual Study Start Date March 7, 2017
Actual Primary Completion Date March 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2017)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: August 21, 2017)
Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in a retrospective cohort of patients at Rennes University Hospital [ Time Frame: Day 1 ]
Electrophoresis rates of serum proteins
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis
Official Title Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with sarcoidosis
Condition Sarcoidosis
Intervention Biological: Analysis of gamma globulin
Electrophoresis of proteins
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2018)
78
Original Estimated Enrollment
 (submitted: August 21, 2017)
100
Actual Study Completion Date March 22, 2017
Actual Primary Completion Date March 22, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03259282
Other Study ID Numbers 35RC16_3046_GAMES
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor Rennes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Rennes University Hospital
Verification Date April 2018