Prospective, Multi-Center Observational Registry of Melanoma CP-GEP and Clinical Outcomes
Merlin CP-GEP Prospective Clinical Registry
The purpose of the registry is to understand how Merlin CP-GEP testing is used in routine care and whether the test result is associated with clinical decision-making in people with melanoma who are 65 years of age or older. The study will also collect available information about treatment decisions and clinical outcomes over time.
研究概览
研究类型
注册 (估计的)
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
取样方法
研究人群
Melanoma patients 65 years of age and older who were tested with the Merlin CP-GEP and obtained a valid result.
描述
Inclusion Criteria:
- Newly diagnosed invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines).
- pT1-pT4 cN0M0
- Male or female, age ≥65 years.
- Merlin CP-GEP testing performed, and a valid result obtained.
- Ability to provide informed consent, or availability of a legally authorized representative when permitted by applicable law and institutional policy.
Exclusion Criteria:
- Documented clinically apparent nodal metastases at diagnosis.
- Distant metastatic disease (M1a, M1b, M1c, or M1d) clinically present at primary diagnosis.
- Documented history of another (prior or concurrent) primary invasive melanoma of T1a or greater at any site in their lifetime.
- Previous surgery or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
- Ocular, vulvar, perianal, or mucosal melanomas, or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
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 |
|---|
|
Newly diagnosed primary cutaneous melanoma patients
Newly diagnosed primary cutaneous melanoma patients, 65 years of age and older, with a valid Merlin CP-GEP result. |
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 |
|---|---|---|
|
Proportion of patients aged 65 years and older with documented integrated use of the Merlin CP-GEP result in clinical decision-making.
大体时间:Clinical data will be collected prospectively for up to three years from enrollment.
|
Clinical impact of the Merlin CP-GEP, evaluated by the percentage of participants aged 65 years and older whose medical records show documented integration of the assay result into clinical management decisions. Documented clinical decision-making includes decisions concerning sentinel lymph node biopsy (SLNB), subsequent surveillance schedules, diagnostic imaging, or adjuvant therapy. |
Clinical data will be collected prospectively for up to three years from enrollment.
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
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
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