Molecular Analysis for Precision Surgery in Thyroid Cancer Trial

NCT06235814 | Completed DMC

• 1 other identifier: IRB#23-001404
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Ideal surgical extent for differentiated thyroid cancer remains unclear. Routine use of molecular analysis in biopsy-proven thyroid cancer could provide important prognostic information to help guide extent of surgery - thyroid lobectomy versus total thyroidectomy. This is a pilot feasibility study for the use of routine molecular analysis in Bethesda V and VI thyroid cancers, with randomization of the intermediate-molecular risk subgroup to thyroid lobectomy and total thyroidectomy. The investigators hypothesize that patients will 1) agree to preoperative molecular analysis, and 2) 50% of intermediate-risk patients will agree to and follow through with randomization. This will be a pilot study for a future randomized controlled trial (RTC) to compare between the two surgical approaches in intermediate-molecular risk thyroid cancer.

Conditions

Papillary Thyroid Cancer

Keywords

Radioactive Iodine; Fine Needle Aspiration; Parathyroid Hormone; Thyroid Stimulating Hormone; Thyroglobulin

Outcome Measures

Primary Outcomes (1)

• Rate of eligible patients who enroll

  Aim 1. Determine feasibility of a future multi-center trial of routine preoperative molecular testing for papillary thyroid cancers to guide extent of therapy. Patients with a new diagnosis of papillary thyroid cancer will undergo routine molecular testing with Thyroseq genomic classifier. Inclusion criteria include age over 18 years and cytology consistent with papillary thyroid cancer. We will exclude patients with hard indications for total thyroidectomy on ultrasound imaging (nodal or distant metastases, extrathyroidal extension). Patients' thyroid cancer molecular profile will be classified as low-, intermediate-, or high-risk based on previous published data.4 Endpoints are related to feasibility of a future trial. Main endpoint will be enrollment rate among eligible patients.

  2 years

Secondary Outcomes (2)

• Rate of patients who complete treatment as assigned

  2 years

• Rate of escalation of care from initially assigned treatment

  2 years

Study Arms (2)

Thyroid Lobectomy

ACTIVE COMPARATOR

Randomization Protocol Patients with intermediate molecular-risk thyroid nodules will be randomized to thyroid lobectomy or total thyroidectomy. We will perform a 1:1 randomization in a consecutive manner. Patients will be informed of what operation they will receive and providers will also be aware what operation was performed as it dictates care moving forward. Details of operative management will be discussed further. Peri-operative Protocol Thyroid Lobectomy Patients undergoing thyroid lobectomy will have the thyroid lobe containing the cancer removed in the standard surgical technique. These operations will be performed at either the UCLA Health Westwood Ambulatory Surgery Center, UCLA Ronald Reagan Medical Center, or UCLA Santa Monica Medical Center. Patients will undergo our usual postoperative care.

Procedure: Molecular Analysis for Thyroid Resection

Total Thyroidectomy

ACTIVE COMPARATOR

Randomization Protocol Patients with intermediate molecular-risk thyroid nodules will be randomized to thyroid lobectomy or total thyroidectomy. We will perform a 1:1 randomization in a consecutive manner. Patients will be informed of what operation they will receive and providers will also be aware what operation was performed as it dictates care moving forward. Details of operative management will be discussed further. Total Thyroidectomy and Completion Thyroidectomy Patients undergoing total thyroidectomy will have their whole thyroid gland removed in the standard surgical technique. Patients undergoing a completion thyroidectomy will have their remaining thyroid lobe removed. These operations will be performed at UCLA Ronald Reagan Medical Center or UCLA Santa Monica Medical Center. Patients will undergo our usual postoperative care.

Procedure: Molecular Analysis for Thyroid Resection

Interventions

Molecular Analysis for Thyroid Resection PROCEDURE

Protocol for Operative Management based on Molecular Risk Classifier Patients will have a televisit (i.e. video-visit) with us in 2 weeks once the ThyroSeq molecular analysis results. In that visit, we will discuss the operation the patient will receive, including the risks and benefits of the operation. Operative management will be dictated by the molecular results listed below: * Low molecular-risk: thyroid lobectomy * High molecular-risk: total thyroidectomy * Intermediate molecular-risk: randomization to thyroid lobectomy or total thyroidectomy Of note, the respective operations for the low and high molecular-risk groups are standard of care.

Thyroid Lobectomy; Total Thyroidectomy

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older at the time of enrollment
• English-speaking
• Bethesda V or VI thyroid nodule that are 1-4cm in size
• Bethesda III or IV nodules who underwent previously underwent Thyroseq molecular analysis that returned with intermediate molecular risk disease

You may not qualify if:

• Prior thyroid operation
• Extrathyroidal extension or lymph node metastases seen on ultrasound
• Distant metastatic disease

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 1, 2024
• Study Start: February 19, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)