Skip to main content
OpenTrials
Completed

NCT Number: NCT02947035

Molecular Testing to Direct Extent of Initial Thyroid Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroid lobectomy

Procedure

Thyroid lobectomy is removal of only part of the thyroid

Total thyroidectomy with CCND

Procedure

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

Primary outcomes

  1. Number of patients who require completion thyroidectomy for aggressive histology features

    Time frame: 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 outcomes

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

    Time frame: 2 years

  2. Number of patients with operative complications

    Time frame: 2 years

    incidence of permanent nerve injury, hypocalcemia, readmission

  3. Recurrence

    Time frame: >2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2016
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.