Molecular Analysis for Precision Surgery in Thyroid Cancer (MAPS) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Rate of eligible patients who enroll
研究概览
简要总结
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.
详细描述
Significance
Incidence of thyroid cancer has substantially increased in the past decade. Papillary thyroid cancers (PTC), typically follow a very indolent course. Although approximately 45,000 patients are diagnosed with thyroid cancer each year, only 2,000 patients die from it with a 5-year survival of over 98%. Thus, there has been a movement to de-escalate care to reduce unnecessary surgical morbidity, and current guidelines recommend consideration of thyroid lobectomy over total thyroidectomy when appropriate. At this time, it is unclear when thyroid lobectomy would be more beneficial than total thyroidectomy. A systematic review of guidelines and expert consensuses from 2009 to 2019 for PTC 1-4 cm in size found that 11 studies recommended total thyroidectomy, 5 recommended thyroid lobectomy, and 3 recommended either depending on patient-centered decision making. Thus, there is an unmet clinical need for improved preoperative risk stratification to determine ideal surgical treatment of thyroid cancer.
Currently, molecular testing is used to determine the risk of malignancy in indeterminate thyroid biopsies. However, these tests have not been used for prognostic purposes in biopsy-proven thyroid cancer. Recent studies have demonstrated that molecular profiling of thyroid cancer is predictive of recurrent disease. Certain high-risk mutations such as TP53, BRAF, and TERT are associated with increased risk of recurrence and fatal disease. Therefore, molecular testing can offer valuable prognostic information to guide treatment.
The investigators propose a feasibility study of a future multicenter study to assess routine use of preoperative molecular testing for risk stratification. The investigators believe that future studies stemming from this proposal will show that for patients with intermediate molecular risk PTC, thyroid lobectomy will have equivalent cancer outcomes to total thyroidectomy. If true, this will reduce the surgical risk and improve quality of life of the tens of thousands of thyroid cancer patients, without compromising cancer outcomes. Ultimately, the investigators hope to reduce overtreatment and morbidity in the treatment of this indolent disease.
Innovation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior thyroid operation
- •Extrathyroidal extension or lymph node metastases seen on ultrasound
- •Distant metastatic disease
研究组 & 干预措施
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.
干预措施: Molecular Analysis for Thyroid Resection (Procedure)
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.
干预措施: Molecular Analysis for Thyroid Resection (Procedure)
结局指标
主要结局
Rate of eligible patients who enroll
时间窗: 2 years
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.
次要结局
- Rate of patients who complete treatment as assigned(2 years)
- Rate of escalation of care from initially assigned treatment(2 years)
研究者
Masha Livhits
Principal Investigator
University of California, Los Angeles