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Procedure

Molecular Analysis for Thyroid Cancer (MAPS Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 18 years or older at the time of enrollment

Bethesda V or VI thyroid nodule that are 1-4cm in size

Must not have

Extrathyroidal extension or lymph node metastases seen on ultrasound

Prior thyroid operation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the use of molecular analysis in thyroid cancer to determine the best type of surgery. The researchers believe that using molecular analysis can provide important information about the cancer and help guide the decision between

Who is the study for?

This trial is for individuals with a confirmed diagnosis of papillary thyroid cancer or other thyroid diseases, specifically those classified as Bethesda V and VI. Participants must be willing to undergo preoperative molecular analysis to guide the surgical approach: partial or complete removal of the thyroid.

What is being tested?

The study is testing whether routine molecular analysis before surgery can help decide if patients should have part (thyroid lobectomy) or all (total thyroidectomy) of their thyroid removed. It's a pilot study that randomly assigns some patients to either surgery based on their molecular risk level.

What are the potential side effects?

Since this trial involves surgical procedures, potential side effects may include typical risks associated with surgeries such as pain, infection at the incision site, bleeding, and possible impacts on voice due to nerve damage near the thyroid.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My thyroid nodule is classified as high risk and is between 1-4cm.

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My thyroid nodule is Bethesda III or IV with intermediate risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thyroid cancer has spread beyond the thyroid or to lymph nodes.

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I have had surgery on my thyroid.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of eligible patients who enroll

Secondary study objectives

Rate of escalation of care from initially assigned treatment

Rate of patients who complete treatment as assigned

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Thyroid LobectomyActive Control1 Intervention

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.

Group II: Total ThyroidectomyActive Control1 Intervention

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.

0 / 6Eligibility criteria met