An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Overall genotype frequencies
研究概览
简要总结
This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.
详细描述
PRIMARY OBJECTIVES:
I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.
II. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.
SECONDARY OBJECTIVES:
I. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pathologically or clinical confirmed tissue diagnosis of a cancer
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients will be excluded if their cancer cannot be confirmed
- •Refusal to sign the informed consent
结局指标
主要结局
Overall genotype frequencies
时间窗: Up to 5 years
The overall genotype frequencies among the cases and expected control levels will first be compared with the frequencies expected from Hardy-Weinberg equilibrium by goodness-of-fit chi-square. Odds ratios and 95% confidence intervals will be used to estimate risk associated with the variant genotypes by using both univariate and unconditional multivariate logistic regression models.
Response to treatment
时间窗: Up to 5 years
The impact of inherited variants on response to treatment will be determined.
Cancer development
时间窗: Up to 5 years
The role of inherited variants in clinical and pathological cancer development will be determined.
Prevalence of germ-line variants
时间窗: Up to 5 years
The prevalence of germ-line variants of interest will be compared to the baseline prevalence found using available large human genomic DNA collections. The primary statistical analysis will involve comparisons of genotypes between with (cases) and without (controls) the germ-line mutation. This analysis will include Pearson's chi-square analysis or Fisher's exact test and computation of odds ratios to assess the relationship of the genetic polymorphism and cancer risk.
次要结局
未报告次要终点