Data Collection for Patients With Low Grade Ovarian Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prospective and retrospective data collection on disease characterization, treatment, and outcomes
研究概览
简要总结
This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.
详细描述
PRIMARY OBJECTIVES:
I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.
II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
III. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.
SECONDARY OBJECTIVE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis:
- •Ovarian tumor of low malignant potential
- •Low-grade serous carcinoma of the ovary
- •Primary peritoneal tumor of low malignant potential
- •Low-grade serous carcinoma of the peritoneum
- •Psammocarcinoma
排除标准
- 未提供
研究组 & 干预措施
Observational (electronic health record review)
Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.
干预措施: Electronic Health Record Review (Other)
Observational (electronic health record review)
Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Prospective and retrospective data collection on disease characterization, treatment, and outcomes
时间窗: Up to 28 years
Organization of clinical information
时间窗: Up to 28 years
Will be done in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
Creation of a single data repository to integrate clinical information and research findings
时间窗: Up to 28 years
次要结局
- Collection and storage of human tumor samples for the establishment of a tumor bank(Up to 28 years)