Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study (GPCBasedow)
Primary Purpose
Graves Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
serodiagnosis
Sponsored by
About this trial
This is an interventional basic science trial for Graves Disease focused on measuring parvovirus genome
Eligibility Criteria
Inclusion Criteria:
- Graves' disease :patients treated for Graves' disease, the diagnosis date less than 4 months
- Control : patients cared for nodules or goiter
Exclusion Criteria:
- Patients undergoing immunosuppressive therapy including corticosteroids
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Graves' disease
Arm Description
patients with goiter or nodule
patients with Graves' disease
Outcomes
Primary Outcome Measures
prevalence of circulating parvovirus genome
Secondary Outcome Measures
Full Information
NCT ID
NCT02798965
First Posted
June 9, 2016
Last Updated
June 15, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02798965
Brief Title
Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
Acronym
GPCBasedow
Official Title
Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
5. Study Description
Brief Summary
Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women. Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis is an interaction between a genetic predisposition and an environmental trigger factor such as viral infection. Parvovirus infections have been proposed as trigger factors for Hashimoto's thyroiditis and Graves' disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
Keywords
parvovirus genome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
patients with goiter or nodule
Arm Title
Graves' disease
Arm Type
Experimental
Arm Description
patients with Graves' disease
Intervention Type
Biological
Intervention Name(s)
serodiagnosis
Primary Outcome Measure Information:
Title
prevalence of circulating parvovirus genome
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Graves' disease :patients treated for Graves' disease, the diagnosis date less than 4 months
Control : patients cared for nodules or goiter
Exclusion Criteria:
Patients undergoing immunosuppressive therapy including corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel DESAILLOUD, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study
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