一项利用循环肿瘤DNA检测为子宫内膜癌患者标准治疗决策提供信息的研究
采用标准治疗方案对晚期/复发性错配修复缺陷（MMR-D）/微卫星不稳定性高（MSI-H）子宫内膜癌进行ctDNA知情免疫检查点抑制剂降阶梯治疗的实用试点研究
The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced/recurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ying Liu, MD, MPH
- 电话号码：646-888-4946
- 邮箱：liuy6@mskcc.org
研究联系人备份
- 姓名：Paul Johannet, MD
- 电话号码：646-888-5327
学习地点
-
-
New Jersey
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Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
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接触：
- Ying Liu, MD
- 电话号码：646-888-4946
-
Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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接触：
- Ying Liu, MD
- 电话号码：646-888-4946
-
Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (All Protocol Activities)
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接触：
- Ying Liu, MD
- 电话号码：646-888-4946
-
-
New York
-
Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
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接触：
- Ying Liu, MD
- 电话号码：646-888-4946
-
Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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接触：
- Ying Lui, MD
- 电话号码：646-888-4946
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center
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接触：
- Roisin O'Cearbhaill, MD
- 电话号码：646-888-4227
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接触：
- Ying Liu, MD, MPH.
- 电话号码：646-888-4946
-
Rockville Centre、New York、美国、11570
- 招聘中
- Memorial Sloan Kettering Nassau (All Protocol Activities)
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接触：
- Ying Liu, MD
- 电话号码：646-888-4946
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Patients must have pathologically confirmed endometrial cancer
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Patients with advanced endometrial cancer
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Stage III with residual disease
°Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI
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Stage IV
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Recurrent endometrial cancer after adjuvant therapy only
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Patients can have primary or planned interval surgery
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MMR-D on immunohistochemistry OR MSI-H using any commercially available test
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Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression.
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Eligible for standard of care chemotherapy with immune checkpoint inhibitor per treating investigator with no clinical contraindications
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For the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments, they need to be on treatment with no clinical evidence of disease progression.
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Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy.
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Patients may have received prior hormonal therapy for treatment of endometrial cancer.
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Patients may not have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
- Except for the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments (chemotherapy and/or immune checkpoint inhibitors) per protocol.
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Age ≥ 18
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Not Pregnant and Not Nursing
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：ctDNA-negative group
Participants in this group will have negative ctDNA test results at 1 year after they start standard treatment. (Negative results indicate that no cancer DNA is detected in their blood.) Participants in this group will decide with their doctor if they want to stop standard maintenance ICI treatment. |
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test. at the 1-year timepoint Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process. Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable. |
|
实验性的：ctDNA-positive group
Participants in this group will have positive ctDNA test results at 1 year after they start standard treatment. (Positive results indicate that cancer DNA is detected in their blood.) Participants in this group will continue receiving standard treatment with their doctor. |
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test. at the 1-year timepoint Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process. Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
will test the feasibility of ct-DNA
大体时间：1 year
|
informed de-escalation of standard of care ICI maintenance therapy defined as willingness of patients/providers to stop ICI therapy after 1 year in those with negative ctDNA testing. |
1 year
|
合作者和调查者
调查人员
- 首席研究员：Ying Liu, MD, MPH、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 25-337
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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