Autoimmune DiseasesEtude thyrovirNCT03114267
Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis
An observational study of Autoimmune Diseases and Chronic Lymphocytic Thyroiditis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Chronic Lymphocytic Thyroiditis
- What is being tested?
- Comparison of the prevalences of the parvovirus genome
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2012to 6 Jan 2015
- Phase
- Observational
- 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
Study population: Patients were recruited after PHRC 2005. Written information for the extension of the study will be sent with a copy of the summary of the scientific publication on Enterovirus (PHRC 2005).
Who may be able to join
- Patients participating in PHRC 2005 "involvement of enteroviruses in TLC pathogenesis"
- Inclusion of TLC: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes
- Inclusion of controls: absence of significant lymphocyte infiltrate
Who cannot join
- Persons refusing to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common.
Viral infections are the main environmental factors suspected of triggering autoimmune diseases. Several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. However, the precise identification of the viruses involved remains to be established.
It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in perioperative specimens of thyroid tissue. However, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies It has been recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.
- Being tested
- Comparison of the prevalences of the parvovirus genome
- Medical subject headings
- Autoimmune Diseases, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the prevalences of the parvovirus genomeOther
Comparison of the prevalences of the parvovirus genome between cases and controls and then of other viruses according to the results of parvoviruses and data from the literature
| Study group | Role | What they receive |
|---|---|---|
| Patient with chronic lymphocytic thyroiditis | Not described Receives: Other: Comparison of the prevalences of the parvovirus genome | |
| Healthy subjects | Not described Receives: Other: Comparison of the prevalences of the parvovirus genome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the viral genome by PCR carried out in the Virology department, Analysis of the presence of capsid protein
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 posted14 Apr 2017
- Study start6 Jan 2012
- Primary completion6 Jan 2015
- Study completion6 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 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
- NCT03114267
- Sponsor's protocol ID
- PI11-PR-DESAILLOUD-1
- Acronym
- Etude thyrovir
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 14 Apr 2017
- 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis
- ClinicalTrials.gov ID
- NCT03114267
- Acronym / sponsor ID
- Etude thyrovir / PI11-PR-DESAILLOUD-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Jan 2012 (actual)
- Primary completion
- 6 Jan 2015 (actual)
- Study completion
- 6 Jan 2015 (actual)
- First posted
- 14 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 diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common.
Viral infections are the main environmental factors suspected of triggering autoimmune diseases. Several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. However, the precise identification of the viruses involved remains to be established.
It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in perioperative specimens of thyroid tissue. However, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies It has been recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic lymphocytic thyroiditis | – | Other: Comparison of the prevalences of the parvovirus genome |
| Healthy subjects | – | Other: Comparison of the prevalences of the parvovirus genome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited after PHRC 2005. Written information for the extension of the study will be sent with a copy of the summary of the scientific publication on Enterovirus (PHRC 2005).
Key inclusion criteria (3 listed)
- Patients participating in PHRC 2005 "involvement of enteroviruses in TLC pathogenesis"
- Inclusion of TLC: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes
- Inclusion of controls: absence of significant lymphocyte infiltrate
Key exclusion criteria (1 listed)
- Persons refusing to participate in research
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 the prevalences of the parvovirus genomeComparison of the prevalences of the parvovirus genome between cases and controls and then of other viruses according to the results of parvoviruses and data from the literature | Other | Healthy subjects, Patient with chronic lymphocytic thyroiditis |
Primary outcome
Analysis of the viral genome by PCR carried out in the Virology department, Analysis of the presence of capsid protein
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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?
An observational study of Autoimmune Diseases and Chronic Lymphocytic Thyroiditis, 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 14 Apr 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analysis of the viral genome by PCR carried out in the Virology department, Analysis of the presence of capsid protein (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 14 Apr 2017.