Molecular Testing to Direct Extent of Initial Thyroid Surgery

Phase 2

Completed

• Conditions: Thyroid Cancer
• Interventions: Procedure: Thyroid lobectomy; Procedure: Total thyroidectomy with CCND

• Registration Number: NCT02947035
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2017-02-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Risk	Thyroid lobectomy	Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy.
High Risk	Total thyroidectomy with CCND	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.

Primary Outcome Measures

Name	Time	Method
Number of patients who require completion thyroidectomy for aggressive histology features	2 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States