AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate baseline measures of physiologic age in relation to short term mortality
研究概览
简要总结
The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy
- •New diagnosis being considered for new line of treatment
- •Age ≥ 50 years.
- •Performance status 0,1, and 2
排除标准
- •Inability to understand or unable to sign a written informed consent
- •Unable to fill out questionnaires on their own and/or do not have someone to help complete them
结局指标
主要结局
Evaluate baseline measures of physiologic age in relation to short term mortality
时间窗: At 30 days and 60 days
Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity
时间窗: At 30 days and 60 days
Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment
时间窗: At baseline, 14 days after treatment, 1 month after treatment
Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year.
时间窗: At baseline, 14 days after treatment, 1 month after treatment
Short physical performance battery (SPPB), geriatric depression scale (GDS), mini-COG, patient reported outcomes of physical function, fatigue, depression, cognition, anxiety
Evaluate baseline measures of physiologic age in relation to complete remission
时间窗: At baseline, 14 days after treatment, 1 month after treatment
Create a predictive pre-treatment screening tool
时间窗: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment
时间窗: At baseline, 14 days after treatment, 1 month after treatment
次要结局
未报告次要终点