Exhalomics for Phenotyping and Real-Time Stratification in Acute Myeloid Leukaemia (EXHALE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- A breath metabolite signature representing AML disease burden
研究概览
简要总结
Patients with acute myeloid leukaemia (AML) respond to treatment to differing degrees, owing to the biological diversity of the disease. The diagnostic tests currently available for identifying genetic alterations and selecting the best possible treatment usually take several days before a result is obtained. In our study, the investigators aim to determine whether breath analysis can detect metabolic products of the leukaemia that allow the disease to be classified rapidly.
Participants will undergo additional blood tests and a breath analysis during their routine appointments. This will take place only during the 1st and 2nd treatment cycles. They will also be asked to complete a questionnaire about their state of health. In addition, the study team will collect further information on their state of health (type of leukaemia, type of treatment, other medications, vital signs) from their medical records.
In total, participants will complete 4 such measurements before and during their treatment. The measurements will be coordinated with their outpatient appointments. No assessments will be carried out unless the participants are at the hospital in any case, and they will not have to attend the hospital more often because of their participation in this study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of an acute myeloid leukaemia and undergoing treatment
- •OR undergoing autoHSCT for lymphoid/myeloma disease in remission
排除标准
- •inability to perform brath analysis
- •anatomical barriers preventing use of the mouthpiece.
研究组 & 干预措施
AML
Patient with the Diagnosis (initial or relapsed/refractory) of AML
Negative Controls
Patients undergoing high-dose Chemotherapy with autologous stem cell support (autoHSCT) due to lymphoma or myeloma in remission
结局指标
主要结局
A breath metabolite signature representing AML disease burden
时间窗: 8 weeks
A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
次要结局
未报告次要终点
研究者
Jeremy Deuel
PD Dr. med. Dr. sc. nat.
University of Zurich
