神经皮肤黑素细胞增多症登记处
包括皮肤和中枢神经系统受累在内的神经皮肤黑素细胞增多症 (NCM) 患者的前瞻性登记
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Yasmin Khakoo, MD
- 电话号码：212-639-8292
- 邮箱：khakooy@mskcc.org
研究联系人备份
- 姓名：Sofia Haque, MD
- 电话号码：212-639-7170
- 邮箱：haques@MSKCC.ORG
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- 尚未招聘
- Boston Children's Hospital (Data Analysis Only)
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接触：
- Elena Hawryluk, MD
- 电话号码：617-355-6117
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New York
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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接触：
- Yasmin Khakoo, MD
- 电话号码：212-639-8292
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
A target sample of 75 patients with LCMN and/or NCM will be enrolled in this registry study. The study is expected to accrue over ≥ 7 years. Currently, an estimated 50 LCMN patients are followed at MSK and we anticipate 25 or more to be referred from outside providers or from new patients seen at MSK. The patient population and the MSK referral base is growing at this time, making this enrollment goal as feasible.
描述
Inclusion Criteria:
-
Patients with LCMN, defined as:
- Dark-colored patch of skin present at birth
- Can be located anywhere on the individual's skin
- May include satellite lesions
- May be associated with hypertrichosis
OR, in absence of cutaneous involvement:
-
histologically or radiographically confirmed CNS melanocytosis.
- Any age at diagnosis.
- Signed informed consent by a patient, or parent/legal guardian.
- Deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death.
Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis.
Exclusion Criteria:
- Informed consent has not been provided.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
|---|
|
Neurocutaneous Melanocytosis
Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
收集全球神经皮肤黑素细胞增多症 (NCM) 患者的回顾性和前瞻性临床、治疗和结果数据
大体时间：长达 7 年
|
长达 7 年
|
合作者和调查者
调查人员
- 首席研究员：Yasmin Khakoo, MD、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
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.