PACE4 in Thyroid Cancer

September 28, 2018 updated by: Robert Day

Evaluation of PACE4 Isoforms as Biomarkers in Thyroid Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients that underwent thyroidectomy at the CIUSSS de l'Estrie-CHUS will be recruited and classified according to the pathological diagnosis. An immunohistochemistry technique, developed and calibrated for the specific protein convertase studied, will be undertaken. Results will be interpreted by a specialized pathologist.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • CIUSSS de l'Estrie - CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Papillary carcinoma, classical variant
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Follicular carcinoma
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Colloid nodule
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Hyperplastic nodule
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Adenomatoid nodule
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Follicular adenoma
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Papillary carcinoma, follicular variant
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Medullary carcinoma
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
Lymphocytic thyroiditis
Diagnostic test: Immunohistochemistry
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression pattern of the studied protein convertase
Time Frame: Trough study completion, an average of 1 year after the patients have been operated.
Horseradish peroxidase staining with specific antibodies.
Trough study completion, an average of 1 year after the patients have been operated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Day

Investigators

  • Principal Investigator: Robert Day, PhD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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