Thyroid NoduleNCT03160482
PACE4 in Thyroid Cancer
An observational study of Thyroid Nodule, run by Robert Day at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Immunohistochemistry
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2017to 15 Jan 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the territory of the CIUSSS de l'Estrie - CHUS, that underwent a subtotal or total thyroidectomy
Who may be able to join
- 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.
Who cannot join
- Refusal to participate to the study.
- Unavailability of the formalin-fixed, paraffin-embedded tissues.
- Uncertain pathological diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Nodule
- Being tested
- Immunohistochemistry
- Keywords
- Thyroid Neoplasm, Thyroid Cancer, Bethesda Classification, Biomarkers, Protein convertase
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryDiagnostic test
Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
| Study group | Role | What they receive |
|---|---|---|
| Papillary carcinoma, classical variant | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Follicular carcinoma | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Colloid nodule | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Hyperplastic nodule | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Adenomatoid nodule | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Follicular adenoma | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Papillary carcinoma, follicular variant | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Medullary carcinoma | Not described Receives: Diagnostic Test: Immunohistochemistry | |
| Lymphocytic thyroiditis | Not described Receives: Diagnostic Test: Immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression pattern of the studied protein convertase
Horseradish peroxidase staining with specific antibodies.
Measured: Trough study completion, an average of 1 year after the patients have been operated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 May 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Day
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Day, Université de Sherbrooke
- Investigators
- Robert Day, PhD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160482
- Sponsor's protocol ID
- 2017-1620
- Status last verified
- Sep 2018
- First submitted
- 16 May 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30340539
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PACE4 Isoforms as Biomarkers in Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03160482
- Acronym / sponsor ID
- 2017-1620
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid Neoplasm, Thyroid Cancer, Bethesda Classification, Biomarkers, Protein convertase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Robert DayUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 19 May 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the territory of the CIUSSS de l'Estrie - CHUS, that underwent a subtotal or total thyroidectomy
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal to participate to the study.
- Unavailability of the formalin-fixed, paraffin-embedded tissues.
- Uncertain pathological diagnosis.
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 |
|---|---|---|
| ImmunohistochemistryImmunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue. | Diagnostic test | Adenomatoid nodule, Colloid nodule, Follicular adenoma, Follicular carcinoma, Hyperplastic nodule, Lymphocytic thyroiditis, Medullary carcinoma, Papillary carcinoma, classical variant, Papillary carcinoma, follicular variant |
Primary outcome
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.
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 2 Oct 2018.
- Derived from this study: PubMed 30340539Fradet 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.
- Individual participant dataSharing planned: No
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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.
Robert Day, PhD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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 Thyroid Nodule, run by Robert Day at 1 site in Canada.
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 2 inclusion and 3 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 2 Oct 2018. 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 Canada. 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?
Expression pattern of the studied protein convertase (time frame: Trough study completion, an average of 1 year after the patients have been operated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160482, which also lists 1 linked publication.
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 2 Oct 2018.