Specimen Banking With Clinical and Genomic Data Registry With the Establishment of Tumor Models for Pediatric Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 35
- 主要终点
- Create a data registry of clinical and molecular/genomic data
研究概览
简要总结
This is an observational data registry study of pediatric cancer patients at participating Beat Childhood Cancer Consortium sites involving specimen banking and data collection.
详细描述
This observational registry and banking study is being performed on a large cohort of subjects who have received molecular testing to better understand the relationship between genomic and molecular information and clinical outcomes, and to enable timely and informed treatment decisions by physicians for their cancers. We hypothesize that large gene panels, sequencing (DNA/RNA), and epigenetics of tumors can identify molecular aberrations that can be leveraged to offer more effective treatment. Findings may highlight additional areas of research required to better understand the molecular underpinnings of the relationship between molecular abnormalities and disease. Banked specimens and the creation of tumor cell lines and xenograft models will facilitate further advancement of this research.
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
- •No age restrictions
- •Subjects that fit into one of the following categories:
- •Subjects with suspected or confirmed cancers of childhood, adolescence, or young adulthood.
- •Survivors of a cancer of childhood, adolescence, or young adulthood (> 6 months off last therapy for cancer)
- •Subjects with a disease-matched condition
- •Healthy volunteers- including any participants with medical conditions that are not disease-matched.
- •Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).
排除标准
- •Subject or his/her legally authorized representative (where applicable) did not consent for specimen banking and data collection for this study.
研究组 & 干预措施
Patients with suspected or confirmed pediatric solid tumors
Patients with suspected or confirmed pediatric solid tumors
干预措施: No intervention- registry only (Other)
结局指标
主要结局
Create a data registry of clinical and molecular/genomic data
时间窗: 10 Years
Create a data registry of clinical and molecular/genomic data from cancer patients who have undergone biopsy or surgical resection for clinical care to better understand the relationship between genomic and molecular information and clinical outcomes.
Determine number and types of genomic alterations within tumor types/subtypes
时间窗: 10 Years
Define genomic landscape of pediatric cancers through the determination of the number and types of genomic alterations within tumor types/subtypes, across tumor types, and tumor evolution over time.
Evaluate the rate of actionable genomic alternations
时间窗: 10 Years
Evaluate the rate of actionable genomic alternations resulting in associated targeted therapies relative to all actionable genomic alterations.
Evaluate the correlation of baseline genomic alterations with clinical outcome.
时间窗: 10 Years
Evaluate the correlation of baseline genomic alterations with clinical outcome.
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
时间窗: 10 Years
Identify biomarkers that predict risk of adverse outcomes that occur following pediatric cancer therapy.
次要结局
- Bank additional specimens available for future research projects(10 Years)
- Develop cell line and xenograft models of pediatric cancers for future research(10 Years)
- Identify biomarkers that predict risks of disease states in subject controls that did not receive cancer therapy.(10 Years)
- Identify biomarkers that may predict risk of disease dependent on sex, race, ethnicity, or the presence of comorbidities.(10 Years)
研究者
Giselle Sholler
Beat Childhood Cancer Chair
Milton S. Hershey Medical Center