Molecular Testing to Direct Extent of Initial Thyroid Surgery

University of Pittsburgh

Status and phase: Completed; Phase 2

Conditions: Thyroid Cancer

Treatments: Procedure: Total thyroidectomy with CCND; Procedure: Thyroid lobectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02947035

STUDY19050280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Low Risk

Experimental group

Description:

Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy.

Treatment:

Procedure: Thyroid lobectomy

High Risk

Experimental group

Description:

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.

Treatment:

Procedure: Total thyroidectomy with CCND