Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis. (IPoTAIG)
Primary Purpose
Polyoma Virus Infection, Thyroiditis, Autoimmune
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
Sponsored by
About this trial
This is an interventional other trial for Polyoma Virus Infection
Eligibility Criteria
Inclusion Criteria:
- Major Patient Age ≥ 18 years
- Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto.
- Patients must have signed informed consent.
- Affiliation to a social security scheme
Exclusion Criteria:
- Minor Patients,
- Patient under tutorship or curatorship.
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients who have Graves disease
Patients having a goiter
Arm Description
Outcomes
Primary Outcome Measures
Investigate the presence of BK Polyomavirus and compare the prevalence in patients operated with goitre or Grave or Hashimoto's disease
Secondary Outcome Measures
Full Information
NCT ID
NCT03103776
First Posted
March 31, 2017
Last Updated
August 20, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03103776
Brief Title
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
Acronym
IPoTAIG
Official Title
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Autoimmune thyroiditis and goitres are frequent pathologies.
Detailed Description
Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic ground, environmental factors are potentially at their origin. Viral infections are the main factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..). However some viruses have an oncogenic potential and could be involved in goitrigenesis. It is also possible that some viruses are specifically implicated in the pathogenesis of Graves' disease or Hashimoto thyroiditis which combines goitre and autoimmunity.
The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is mainly known for triggering renal and bladder pathologies including urothelial tumors in the immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient, as well as hemorrhagic cystitis in the patient grafted to the bone marrow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyoma Virus Infection, Thyroiditis, Autoimmune
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients who have Graves disease
Arm Type
Other
Arm Title
Patients having a goiter
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
Intervention Description
Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
Primary Outcome Measure Information:
Title
Investigate the presence of BK Polyomavirus and compare the prevalence in patients operated with goitre or Grave or Hashimoto's disease
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Patient Age ≥ 18 years
Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto.
Patients must have signed informed consent.
Affiliation to a social security scheme
Exclusion Criteria:
Minor Patients,
Patient under tutorship or curatorship.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
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