Molecular Testing to Direct Extent of Initial Thyroid Surgery

Thyroid Cancer Clinical Trial

Official title:

Molecular Testing to Direct Extent of Initial Thyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947035
• Other study ID #: STUDY19050280
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Thyroid lobectomy
Thyroid lobectomy is removal of only part of the thyroid
• Total thyroidectomy with CCND
Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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