Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,030
- 试验地点
- 2
- 主要终点
- Patients' experience with the different phases of MTC
研究概览
简要总结
This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.
详细描述
PRIMARY OBJECTIVES:
I. To describe the natural history of medullary thyroid cancer (MTC) using a comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in our existing multi-institutional patient registry.
Ia. To describe the demographic, clinical, pathologic, and genotypic variables associated with each phase of disease.
Ib. To identify those variables which are predictors of progression to the most advanced phases of disease that require small molecule therapy, including commercially approved and experimental agents.
II. To characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
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
- 否
入选标准
- •Aims 1 and 2: A diagnosis of MTC
- •Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment
- •Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team
- •Aim 3: A current registrant in the MTCR
排除标准
- 未提供
研究组 & 干预措施
Observational (questionnaire, blood pressure)
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.
AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.
干预措施: Blood Pressure Measurement (Other)
Observational (questionnaire, blood pressure)
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.
AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Patients' experience with the different phases of MTC
时间窗: Up to 4 years
Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
Natural history of medullary thyroid cancer (MTC)
时间窗: Up to 4 years
Will describe the natural history of MTC using comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in existing multi-institutional patient registry.
Association of selected biometric and patient-reported outcomes
时间窗: Up to 4 years
Will evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.
次要结局
未报告次要终点