Blood and Tumor Sample Collection From Patients With Malignant Melanoma for Long Term Storage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Collection and long-term collection of blood and tumor samples from patients with malignant melanoma for future biological and/or surrogate marker studies.
研究概览
简要总结
The goal of this laboratory research study is to collect blood and tumor samples from patients with malignant melanoma. Researchers want to store these samples in a secure and confidential laboratory at M. D. Anderson. Researchers will use the information that is learned in this study to help find ways to improve treatment for melanoma and other cancers.
详细描述
Researchers at M. D. Anderson want to learn as much as possible about melanoma and other cancers. One way researchers can learn more about cancer is by studying what is in your blood and in your tumor.
If you agree to take part in this study, the way you participate will depend on if you are being treated for cancer. If you are receiving any form of chemotherapy, you will have about 4 1/2 tablespoons of blood drawn before you start the first day of treatment. You will then have about 3 tablespoons of blood drawn every 6 to 8 weeks for the next 6 months. You will have a total of up to about 5 blood draws for this portion of the study. You will have the above blood draws during routine visits so that no additional visits will be required.
If you are receiving "immunologic or targeted" cancer treatment, you will have blood drawn for testing. Immunologic treatment is a kind of treatment which boosts your immune system to fight your cancer. Targeted cancer treatment is a kind of treatment which disrupts the functions of proteins that are needed for tumor growth. About 4 1/2 tablespoons of blood drawn before you start the first day of treatment. You will then have about 3 tablespoons of blood drawn 1 time during the first 2 weeks (Days 2-14), 1 time during the second 2 weeks (Days 15-28), 1 time during second or third month (Days 29 - 90), and then once every 3 months for up to 5 years. A total of no more than 25 samples will be drawn.
After the 6-month period, if follow-up is scheduled for you at M. D. Anderson, you will have about 3 tablespoons of blood drawn (during the follow-up visits) once every 3 months for the next 5 years. You will have a total of 20 blood draws for this portion of the study. During your follow-up, you will have a routine clinic visit to monitor any tumor recurrences (occurring again). You will continue to have this visit about every 2 to 6 months, depending on the risk of any tumor recurrence.
If you are not receiving any form of cancer treatment, you will have about 4 1/2 tablespoons of blood drawn on the day that you enroll in this study. If you agree (it is your choice) to participate in the follow-up portion of this study, you will have about 3 tablespoons of blood drawn (during the follow-up visits) once every 3 months for the next 5 years. You will have a total of about 21 blood draws for this portion of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a suspected or confirmed diagnosis of malignant melanoma. These include patients with melanoma of the soft part, spindle-cell neoplasm consistent with melanoma and choroidal melanoma.
- •Patients who are willing to consent for this protocol.
排除标准
- 未提供
结局指标
主要结局
Collection and long-term collection of blood and tumor samples from patients with malignant melanoma for future biological and/or surrogate marker studies.
时间窗: 6 Years
次要结局
未报告次要终点