Molecular Testing to Direct Extent of Initial Thyroid Surgery

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: Thyroid lobectomy; Procedure: Total thyroidectomy with CCND

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Risk; 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; Thyroid lobectomy is removal of only part of the thyroid
Experimental: High Risk; 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; Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Linwah Yip, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimated): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: thyroid cancer; thyroidectomy; personalized medicine; thyroid nodule
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: STUDY19050280

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