NCT03160482

Brief Summary

The investigation of thyroid nodules is limited by the fact that up to 49% of the fine needle aspirations (FNA) performed are of "indeterminate cytological signification". Moreover, no fully reliable molecular marker for thyroid cancer have been described. The goal of this project is to study the expression of a specific kind of protein convertase in benign and in malignant thyroid nodules to determine its potential as a biomarker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

May 16, 2017

Last Update Submit

September 28, 2018

Conditions

Thyroid Nodule

Keywords

Thyroid NeoplasmThyroid CancerBethesda ClassificationBiomarkersProtein convertase

Outcome Measures

Primary Outcomes (1)

  • Expression pattern of the studied protein convertase

    Horseradish peroxidase staining with specific antibodies.

    Trough study completion, an average of 1 year after the patients have been operated.

Study Arms (9)

Papillary carcinoma, classical variant

Diagnostic Test: Immunohistochemistry

Follicular carcinoma

Diagnostic Test: Immunohistochemistry

Colloid nodule

Diagnostic Test: Immunohistochemistry

Hyperplastic nodule

Diagnostic Test: Immunohistochemistry

Adenomatoid nodule

Diagnostic Test: Immunohistochemistry

Follicular adenoma

Diagnostic Test: Immunohistochemistry

Papillary carcinoma, follicular variant

Diagnostic Test: Immunohistochemistry

Medullary carcinoma

Diagnostic Test: Immunohistochemistry

Lymphocytic thyroiditis

Diagnostic Test: Immunohistochemistry

Interventions

ImmunohistochemistryDIAGNOSTIC_TEST

Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.

Adenomatoid noduleColloid noduleFollicular adenomaFollicular carcinomaHyperplastic noduleLymphocytic thyroiditisMedullary carcinomaPapillary carcinoma, classical variantPapillary carcinoma, follicular variant

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the territory of the CIUSSS de l'Estrie - CHUS, that underwent a subtotal or total thyroidectomy

You may qualify if:

  • Men of women, aged 18-100 y.-o.
  • History of subtotal or total thyroidectomy at the "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke" (CIUSSS de l'Estrie - CHUS) between January 2010 and May 2016.

You may not qualify if:

  • Refusal to participate to the study.
  • Unavailability of the formalin-fixed, paraffin-embedded tissues.
  • Uncertain pathological diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Related Publications (1)

  • Fradet L, Temmar R, Couture F, Belzile M, Fortier PH, Day R. Evaluation of PACE4 isoforms as biomarkers in thyroid cancer. J Otolaryngol Head Neck Surg. 2018 Oct 19;47(1):63. doi: 10.1186/s40463-018-0311-x.

    PMID: 30340539DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed, paraffin-embedded thyroid tissue, kept at the CIUSSS de l'Estrie - CHUS Pathology archives

MeSH Terms

Conditions

Thyroid NoduleThyroid Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Robert Day, PhD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

May 15, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)