NCT03103776

Brief Summary

Autoimmune thyroiditis and goitres are frequent pathologies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

March 31, 2017

Last Update Submit

August 20, 2018

Conditions

Polyoma Virus InfectionThyroiditis, Autoimmune

Outcome Measures

Primary Outcomes (1)

  • Investigate the presence of BK Polyomavirus and compare the prevalence in patients operated with goitre or Grave or Hashimoto's disease

    1 day

Study Arms (2)

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

Interventions

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

Patients having a goiterPatients who have Graves disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Minor Patients,
  • Patient under tutorship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Polyomavirus InfectionsThyroiditis, Autoimmune

Interventions

Blood Specimen CollectionUrination

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfectionsThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

March 22, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

FR(1)