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Molecular Testing to Direct Extent of Initial Thyroid Surgery

Primary Purpose

Thyroid Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Thyroid lobectomy

Total thyroidectomy with CCND

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Pittsburgh
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low Risk

High Risk

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients who had central compartment neck dissection but no lymph node metastasis were identified

Number of patients with operative complications

incidence of permanent nerve injury, hypocalcemia, readmission

Recurrence

QOL metric - FACT-G cumulative score preop, postop, and at followup

QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup

QOL metric - SF36 cumulative score preop, postop, and at followup

Full Information

NCT ID

NCT02947035

First Posted

October 20, 2016

Last Updated

July 12, 2023

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT02947035

Brief Title

Molecular Testing to Direct Extent of Initial Thyroid Surgery

Official Title

Molecular Testing to Direct Extent of Initial Thyroid Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

June 1, 2023 (Actual)

Study Completion Date

June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer

Keywords

thyroid cancer, thyroid nodule, thyroidectomy, personalized medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Risk

Arm Type

Experimental

Arm Description

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

Arm Title

High Risk

Arm Type

Experimental

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Thyroid lobectomy

Intervention Description

Thyroid lobectomy is removal of only part of the thyroid

Intervention Type

Procedure

Intervention Name(s)

Total thyroidectomy with CCND

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients who require completion thyroidectomy for aggressive histology features

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of patients who had central compartment neck dissection but no lymph node metastasis were identified

Time Frame

2 years

Title

Number of patients with operative complications

Description

incidence of permanent nerve injury, hypocalcemia, readmission

Time Frame

2 years

Title

Recurrence

Time Frame

>2 years

Title

QOL metric - FACT-G cumulative score preop, postop, and at followup

Time Frame

2 years

Title

QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup

Time Frame

2 years

Title

QOL metric - SF36 cumulative score preop, postop, and at followup

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linwah Yip, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Molecular Testing to Direct Extent of Initial Thyroid Surgery

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