INST UNM 1521: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 47,500
- 试验地点
- 1
- 主要终点
- Amount of clinical patient demographic data collected for a repository linked to clinical data for long-term research use.
研究概览
简要总结
The overall objective of this study is to ultimately develop an improved standard of cancer care by facilitating new cancer research, clinical trials, new technology, new informatics solutions, and "personalized medicine" for the University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Oncology Research Information Exchange Network (ORIEN) Consortium of academic medical centers, community hospital systems, and other health care providers. To bring new translational research to the community, the ORIEN consortium has initiated the ORIEN Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of patients with cancer or at risk of having cancer. This is not a treatment trial. It is a study designed to create a centralized data and tissue repository.
详细描述
Through this protocol, UNMCCC and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, the investigators require the permission of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •18 years of age and older.
- •Has a diagnosis of cancer or is suspected of having cancer.
- •Able to understand and sign the Informed Consent form directly.
- •Pregnant women are permitted to be enrolled.
排除标准
- •Prisoners
结局指标
主要结局
Amount of clinical patient demographic data collected for a repository linked to clinical data for long-term research use.
时间窗: up to 20 years
Establish a longitudinal clinical data repository that will contain information about patient demographics collected via surveys and questionnaires.
Amount of clinical patient medical treatment and outcome data collected via medical histories for long-term research use
时间窗: up to 20 years
Establish a longitudinal clinical data repository that will contain information about medical treatments and patient outcomes collected via medical chart review and patient medical histories.
Number of biospecimens collected for a tissue repository linked to clinical data for long-term research use
时间窗: up to 20 years
Establish a longitudinal tissue repository that will contain tissues (blood, tumor tissue) and other biological samples and associated clinical data collected from consenting patients.
次要结局
未报告次要终点