Molecular Testing to Direct Extent of Initial Thyroid Surgery

NCT02947035 | Completed Phase 2 DMC

• 1 other identifier: STUDY19050280
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Thyroid Cancer

Keywords

thyroid cancer; thyroid nodule; thyroidectomy; personalized medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (2)

Low Risk

EXPERIMENTAL

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

High Risk

EXPERIMENTAL

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

Interventions

Thyroid lobectomy PROCEDURE

Thyroid lobectomy is removal of only part of the thyroid

Low Risk

Total thyroidectomy with CCND PROCEDURE

Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes

High Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thyroid nodule is \>1.5 cm
• Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Interventions

Cyclin D

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Cyclins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Cell Cycle Proteins; Proteins

Study Officials

• Linwah Yip, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 27, 2016
• Study Start: February 1, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)