Molecular Analysis for Precision Surgery in Thyroid Cancer (MAPS) Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Young-Ji Seo, MD
yseo@mednet.ucla.edu
310 206-9145
Backup
Elena G Hughes
eghughes@mednet.ucla.edu
310-794-9220
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2026-04-08
Participants
Target number of participants: 125
Treatments
Active_comparator: Thyroid Lobectomy
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.
Active_comparator: Total Thyroidectomy
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.
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov