Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Patient treatment data
研究概览
简要总结
This study collects information and data on patients with neuroendocrine cervical cancer. Information from this study may be used to better understand the correlation between clinical data, such as patient characteristics, treatment, and disease outcomes, and overall patient outcomes.
详细描述
PRIMARY OBJECTIVES:
I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for patients with neuroendocrine carcinoma of the uterine cervix.
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 an archive for future research.
OUTLINE:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a personal history of cervical cancer with any portion of neuroendocrine component (including mixed tumors) of the following histologic subtypes:
- •Small cell neuroendocrine carcinoma
- •Large cell neuroendocrine carcinoma
- •Undifferentiated high-grade neuroendocrine carcinoma
- •Patients may be in any stage of treatment, surveillance or recurrence at the time of initial participation in the study
- •Patients with all stages of disease are considered eligible
- •Patients who do not speak English can be eligible if accompanied by an institutional interpreter
- •Patients who are receiving or have received treatment at any facility, including but not limited to M. D. Anderson Cancer Center are eligible
- •Patient may be residents of any country and be of any ethnic background
- •Patients who request to participate in the study, regardless of the method by which they learned of it, are eligible to participate, including, but not limited to patients who seek participation via the website
- •Next of kin or legal authorized representatives of patients who are deceased but had a history of neuroendocrine carcinoma (NEC) of the cervix are eligible to participate
- •Next of kin or legal authorized representatives of patients must read and speak English
排除标准
- •Patients with other histologic subtypes of NEC of the cervix including typical and atypical carcinoid tumors
研究组 & 干预措施
Observational (medical chart review)
Patients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients.
干预措施: Follow-Up (Other)
Observational (medical chart review)
Patients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Patient treatment data
时间窗: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
Disease characterization data
时间窗: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
Patient outcome data
时间窗: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
次要结局
未报告次要终点