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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Polyoma Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 31, 2017
Last Updated
August 20, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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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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