Confronting Cancer as a Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study aims to better understand the cause of colorectal cancer and how to find the best treatment for Hispanic patients with colorectal cancer. The genetic information in the blood and tissues may explain why patients who have the same type of cancer and receive the same treatment do not always have the same results. By combining genetic (certain qualities or traits passed from parents to offspring) information with clinical data, such as the responses of different kinds of cancers to different treatments, this study could lead to more knowledge about why certain cancers occur and why they respond differently to treatments. Information gathered from this study may help researchers match treatments to the genetics of each patient and the genetic changes in their tumor. This approach is known as personalized medicine.
详细描述
PRIMARY OBJECTIVE:
I. To create a well-characterized cohort of Hispanic patients with colon cancer, with patient-level data, genomic, transcriptomic, clinical, and outcomes data.
SECONDARY OBJECTIVES:
I. To identify genomic/transcriptomic predictors of treatment outcomes (time to recurrence, time to progression, and overall survival).
II. To identify associations between somatic tumor deoxyribonucleic acid (DNA) methylation patterns and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported Hispanic ethnicity
- •Diagnosed with colon or rectal cancer (at any time and stage; lifetime diagnosis and in survival are eligible)
- •Has a tumor tissue sample archived or plans to have tissue archived from a standard care procedure
- •Age >= 18 years
- •Ability to understand and the willingness to sign a written informed consent.
- •For those who would like to participate in the optional microbiome characterization aspect of the study, the patient will have to be under 40 years old at any clinical cancer stage or over 60 years old at any clinical cancer stage.
排除标准
- •Inability to understand and the willingness to sign a written informed consent
研究组 & 干预措施
Arm 2: Intervention
Patients will receive CoGenes educational materials and video prior to the return of their results to better understand the results. The goal is to provide education about the benefits of genetic and tumor testing and to increase the patient's knowledge.
干预措施: Intervention Educational Materials (Other)
Arm 1: Usual Care
Patients will receive standard educational materials prior to the return of their results to better understand the results.
干预措施: Usual Care Educational Materials (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: Assessed up to 6 years
Determined from start of treatment until death due to any cause.
Time to recurrence (TTR)
时间窗: Assessed up to 6 years
Determined from time of registration to date of documented event such as treatment-related deaths, second same or other primary cancers, and deaths from other cancers.
Progression free survival (PFS)
时间窗: Assessed up to 6 years
Determined from start of treatment to time of progression or death (whichever comes first).
Changes in genomic knowledge
时间窗: Baseline, at 2 weeks, and at 12-month follow up
The KnowGene scale will be used. Score Range = 0-16. Higher score indicates higher knowledge.
次要结局
未报告次要终点