Early Onset Malignancies Initiative (EOMI): Molecular Profiling of Breast, Colon, Kidney, Liver, Multiple Myeloma, and Prostate Among Racially and Ethnically Diverse Populations
概览
- 阶段
- 不适用
- 干预措施
- Biospecimen Collection
- 疾病 / 适应症
- Breast Carcinoma
- 发起方
- National Cancer Institute (NCI)
- 入组人数
- 2400
- 试验地点
- 1
- 主要终点
- Acquisition of tissue, blood, and other biospecimens for research purposes
- 状态
- 暂停
- 最后更新
- 19天前
概览
简要总结
This research trial studies how well biospecimen collection works in identifying genetic changes in patients with breast, prostate, colorectal, liver, or kidney cancer or multiple myeloma undergoing surgery. Studying samples collected during surgery may add to the understanding of cancer by looking for the genetic changes that cause early cancer onset in people of certain racial and ethnic groups.
详细描述
PRIMARY OBJECTIVE: I. To acquire tissue and blood, and other biospecimens for research purposes during procedures for clinical care to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large- scale genome sequencing and clinical data analysis. OUTLINE: Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing. After completion of study, patients are followed for up at 6 and 12 months.
研究者
入排标准
入选标准
- •Patients with either:
- •Histologically confirmed invasive carcinoma or multiple myeloma OR
- •Clinical diagnosis of carcinoma or multiple myeloma OR
- •Suspected clinical diagnosis of multiple myeloma
- •Patients with one of following tumor types and age ranges:
- •Breast cancer diagnosis at ages 18-45
- •Colon cancer diagnosis at ages 18-55
- •Kidney cancer at diagnosis at ages 18-50 (American Indian or Alaska Native \[AIAN\] and non-Hispanic Whites \[NHW\] only)
- •Liver cancer diagnosis at ages 18-55
- •Prostate cancer diagnosis at ages 18-55
排除标准
- •Patients who do not meet criteria for an early onset malignancy
- •Prior systemic therapy or radiation therapy for their malignancy
- •Tumor does not meet quality metrics
- •Patient refused consent for use of tissue for research activities included in the Early Onset Malignancies Initiative
- •A diagnosis of a synchronous invasive malignancy
- •Patients with a history of invasive cancer or hematologic malignancy in preceding 5 years
研究组 & 干预措施
Ancillary-correlative (biospecimen collection)
Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.
干预措施: Biospecimen Collection
Ancillary-correlative (biospecimen collection)
Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.
干预措施: Laboratory Biomarker Analysis
结局指标
主要结局
Acquisition of tissue, blood, and other biospecimens for research purposes
时间窗: Up to 3 years
Will be performed.