Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Establishment of a tissue repository for the collection and banking of tissue samples
研究概览
简要总结
Background:
A person s blood, tissue, and other samples contain DNA. Cancer is a disease of cells that are not working properly. It is caused by changes in DNA that build up. Researchers want to do future studies on DNA changes This may help them learn how to guide treatment for cancer. They need biological samples like tumors, blood, and urine for these studies.
Objective:
To create a place to collect and store biological samples from people with gynecologic malignancies like breast cancer. Samples from certain relatives of theirs will be collected too.
Eligibility:
Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic malignancy
Their biological relatives of the same age
Design:
Participants will answer questions about their family history.
Participants will have a physical exam and medical history. This will include questions about age, ethnicity, and disease history. They will also answer questions about their medical treatments and responses.
Participants will give blood and urine samples.
Participants may give a tumor tissue sample. This will not be taken specifically for this study. It will be from a previous procedure or one that is already planned.
Other samples may be taken only if a procedure is required for treatment. These include bone marrow, cerebrospinal fluid, and other fluids.
A group of doctors and other professionals will oversee the sample storage place. The group will review all requests to be sure the use of the specimens is valid.
详细描述
Background:
Increased understanding of the genomic variations of cancer through laboratory evaluations can result in breakthroughs in treatment and improved patient outcomes.
Exceptional responders on clinical trials may have mutational characteristics that are unique and unknown, necessitating identification.
Current drug development strategies employ precision oncology. This approach identifies molecular targets, with therapies being either chosen or developed to interact with the specific target.
The collection and banking of a variety of tissue samples for future translational studies would support research and advance the mission of the NIH.
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
- 是
入选标准
- •INCLUSION CRITERIA:
- •Adult subject (age 18 and older) co-enrolled on a trial, or otherwise undergoing consultation, screening, or follow up on existing protocols conducted at the NIH Clinical Center, who are evaluated in the Women s Malignancies Branch Clinic.
- •Participant or biological relative of a participant, as follows:
- •Participant with a histologically confirmed breast cancer or other gynecologic malignancy; histopathology of the biopsy tissue must be
- •confirmed by the NCI Laboratory of Pathology, prior to banking of the tissue on this protocol.
- •Biological relative (1st -3rd degree) of a participant who meets the eligibility of histologically confirmed malignancy per above
- •Subject willingness and ability to provide informed consent.
- •Subject willingness to provide tissue samples for banking.
排除标准
- •- Pregnant women are not eligible to take part; pregnancy will be assessed using clinical criteria (medical history and physical exam).
研究组 & 干预措施
Patients
Participants with histologically confirmed malignancy
Patient Relatives
Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
结局指标
主要结局
Establishment of a tissue repository for the collection and banking of tissue samples
时间窗: at study completion
A tissue repository
次要结局
未报告次要终点