Molecular Testing to Direct Extent of Initial Thyroid Surgery

NCT ID: NCT02947035

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2023-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Risk

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

Group Type EXPERIMENTAL

Thyroid lobectomy

Intervention Type PROCEDURE

Thyroid lobectomy is removal of only part of the thyroid

High Risk

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.

Group Type EXPERIMENTAL

Total thyroidectomy with CCND

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thyroid lobectomy

Thyroid lobectomy is removal of only part of the thyroid

Intervention Type PROCEDURE

Total thyroidectomy with CCND

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Linwah Yip

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Linwah Yip, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY19050280

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.