Multi - Center Database/Registry of Subjects at High Risk for Ovarian or Breast Cancer - A Lynne Cohen Consortium Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 4
- 主要终点
- Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer
研究概览
简要总结
Goals of this registry:
1.1 To collect and store very limited demographic information (age, birthdate, race and ethnicity), limited cancer risk and breast and ovarian disease history, as well as limited family history of breast and ovarian cancer on patients who are at risk of breast or ovarian cancer or who have had a diagnosis of either cancer,
1.2 To make available summary information (in an anonymous form) regarding the subjects in this registry to Consortium members, and other investigators, who can use these data to plan research projects and evaluate the feasibility of such projects,
1.3 To make available summary information (number of new patients seen in the clinic, number of mutations, number of preventive surgeries, average age of patients seen) to the Lynne Cohen Foundation for Ovarian Cancer Research, in order to document the numbers of subjects who utilize their supported clinics.
详细描述
Information Collection for Entry into Multicenter Registry:
If you agree to take part in this study, a study staff member will collect the following information by asking you at a clinic visit and checking your medical records. The following information will be entered in the registry:
your demographic information (your sex, year of birth, and race/ethnicity) whether any member of your family has a history of ovarian and/or breast cancer whether any member of your family has any known genetic markers that may mean a higher risk of developing a cancer a brief summary of your history of breast and/or ovarian disease and whether you have any known genetic markers that may mean a higher risk of developing breast and/or ovarian cancer a brief summary of the results of the clinic visit on the day you agreed to take part in this study (Day 1)
Follow-Up Information Collection:
Each time you visit the M. D. Anderson high-risk clinic (either the high-risk breast cancer clinic or the high-risk ovarian cancer clinic), the study staff will check your medical records and enter in the registry any updates to your cancer risk information. You will also be asked if any family members have been diagnosed with ovarian and/or breast cancer, and this will be entered in the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are 18 or older and meet one or more of the following criteria.
- •Personal history of breast and/or ovarian cancer.
- •Family history of breast and/or ovarian cancer (one or more relatives).
- •Carrier of a mutation in the BRCA1 or BRCA 2 gene, or the presence of one of these mutations in a family member.
排除标准
- 未提供
结局指标
主要结局
Collection of Demographic and Cancer Risk Information on Women Who Are at High Risk for Ovarian or Breast Cancer
时间窗: 9 Years
次要结局
- Establish Repository of Minimal Basic Data (Multicenter Registry)(9 Years)