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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 belowSelect...
I am 18 years old or older.
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My thyroid nodule is classified as high risk and is between 1-4cm.
Select...
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:Select...
My thyroid cancer has spread beyond the thyroid or to lymph nodes.
Select...
I have had surgery on my thyroid.
Select...
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
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.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,566 Previous Clinical Trials
10,263,329 Total Patients Enrolled
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