Analysis of the Tumor Microenvironment and Immune Response in Malignant Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- New prognostic markers in malignant melanoma
研究概览
简要总结
This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease.
详细描述
PRIMARY OBJECTIVE:
I. Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma.
OUTLINE:
Patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). Patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. Healthy individuals undergo collection of blood samples up to 4 times over 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with malignant melanoma or personal history of melanoma
- •Normal donors
- •Informed consent can be obtained
- •Patients with any stage of malignant melanoma
排除标准
- •Incarcerated individuals will be excluded from this protocol
研究组 & 干预措施
Ancillary-correlative (biospecimen collection)
Patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). Patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. Healthy individuals undergo collection of blood samples up to 4 times over 1 year.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
New prognostic markers in malignant melanoma
时间窗: Up to 3 months
Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma. . Draws conducted at baseline prior to immune therapy, four weeks after draw 1 and prior to the third cycle.
次要结局
未报告次要终点
研究者
William Carson
Principal Investigator
Ohio State University Comprehensive Cancer Center