Molecular Testing to Direct Extent of Initial Thyroid Surgery

Study Overview
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Brief Summary
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The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.

Detailed Description
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The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.

Official Title
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Molecular Testing to Direct Extent of Initial Thyroid Surgery

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Procedure: Thyroid lobectomy
* Procedure: Total thyroidectomy with CCND


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thyroid nodule is >1.5 cm Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer Exclusion Criteria: Prior thyroid/parathyroid surgery Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when <18 years old Recurrent laryngeal nerve dysfunction Diagnosis of concurrent primary hyperparathyroidism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Risk<br>Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy. | Procedure: Thyroid lobectomy<br>* Thyroid lobectomy is removal of only part of the thyroid<br>|
| Experimental: High Risk<br>Molecular testing and ultrasound features will be used to predict if thyroid cancer is high risk. Intervention will be to perform more aggressive surgery to include total thyroidectomy with CCND. | Procedure: Total thyroidectomy with CCND<br>* Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who require completion thyroidectomy for aggressive histology features | Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had central compartment neck dissection but no lymph node metastasis were identified |  | 2 years | 
| Number of patients with operative complications | incidence of permanent nerve injury, hypocalcemia, readmission | 2 years | 
| Recurrence |  | >2 years | 
| QOL metric - FACT-G cumulative score preop, postop, and at followup |  | 2 years | 
| QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup |  | 2 years | 
| QOL metric - SF36 cumulative score preop, postop, and at followup |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine