Polyoma Virus InfectionIPoTAIGNCT03103776
Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
A study testing Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto in people with Polyoma Virus Infection and Thyroiditis, Autoimmune, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Autoimmune thyroiditis and goitres are frequent pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyoma Virus Infection, Thyroiditis, Autoimmune
- What is being tested?
- Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2016to 26 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor Patients,
- Patient under tutorship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Autoimmune thyroiditis and goitres are frequent pathologies.
Read the 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.
- Conditions
- Polyoma Virus Infection, Thyroiditis, Autoimmune
- Being tested
- Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
- Medical subject headings
- Polyomavirus Infections, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / HashimotoOther
Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
| Study group | Role | What they receive |
|---|---|---|
| Patients who have Graves disease | Other | Not described Receives: Other: Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto |
| Patients having a goiter | Other | Not described Receives: Other: Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the presence of BK Polyomavirus and compare the prevalence in patients operated with goitre or Grave or Hashimoto's disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start22 Mar 2016
- Primary completion26 Dec 2017
- Study completion26 Dec 2017
Why it stopped: Recruitement problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyoma Virus InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103776
- Sponsor's protocol ID
- PI2015_843_0033
- Acronym
- IPoTAIG
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2017
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
- ClinicalTrials.gov ID
- NCT03103776
- Acronym / sponsor ID
- IPoTAIG / PI2015_843_0033
- Conditions
- Polyoma Virus Infection, Thyroiditis, Autoimmune
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitement problem
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who have Graves disease | Other | Other: Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto |
| Patients having a goiter | Other | Other: Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Minor Patients,
- Patient under tutorship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / HashimotoComparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto | Other | Patients having a goiter, Patients who have Graves disease |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Recruitement problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto in people with Polyoma Virus Infection and Thyroiditis, Autoimmune, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitement problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.