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

April 10, 2018 updated by: Rennes University Hospital
Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in a retrospective cohort of patients at Rennes University Hospital

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with sarcoidosis

Description

Inclusion Criteria:

- Patients newly diagnosed with sarcoidosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2017

Primary Completion (Actual)

March 22, 2017

Study Completion (Actual)

March 22, 2017

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC16_3046_GAMES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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