A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tempus AI
- 入组人数
- 550
- 试验地点
- 10
- 主要终点
- To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.
研究概览
简要总结
The TEMPUS AQUARIUS Study is a non-interventional, longitudinal observational study focused on hematological malignancies. It will collect rich molecular (multi-omic) and clinical data from patient cohorts through serial blood draws and the acquisition of leftover tissue and/or bone marrow aspirates during their routine therapy and disease monitoring. The primary goal is to understand the association between biomarkers and real-world clinical outcomes in these patient populations.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Cohorts Inclusion Criteria:
- •Willing and able to participate in the research and provide biospecimens
- •Willing and able to provide informed consent
- •Cohort 001 Inclusion:
- •Have documented diagnosis of AML according to the World Health Organization (WHO) classification
- •Secondary AML is allowed
- •Cohort 002 Inclusion:
- •Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D)
- •Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D)
- •002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation
- •002B (Newly Diagnosed, High Risk): Intended for first line treatment
- •002B (Newly Diagnosed, High Risk): Meets the criteria for high risk by any of the following: Follicular Lymphoma Inernational Prognostic Index (FLIPI) High Risk, Groupe d'Etude des Lymphomes Follicularies (GELF) High Tumor Burden, Lactate Dehydrogenase (LDH) above the upper limit of normal (ULN)
- •002C (Relapsed / Refractory High Risk POD24 FL): Documented progression of disease within 24 months (POD24) of first line follicular lymphoma treatment, prior to second line treatment
- •002D (Transformed FL): Pathologically confirmed transformation
- •All Cohorts
排除标准
- •1. Not willing or able to adhere with the study procedures
- •Cohort 001:
- •1. Have received any prior therapy intended for standard of care (SoC) treatment of AML
- •Cohort 002:
- •002A: Received prior treatment for follicular lymphoma
- •002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
- •002A: Resected patients with NED
- •002B: Intended for active observation
- •002B: Received prior treatment for follicular lymphoma
研究组 & 干预措施
Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML)
Newly diagnosed patients with a primary or secondary diagnosis of Acute Myeloid Leukemia (AML)
干预措施: None - Observational Study (Other)
Cohort 002: Folicular Lymphoma
Cohort 002 contains four subgroups of Follicular Lymphoma (FL): A: Newly Diagnosed FL on Active Observation; B: Newly Diagnosed High Risk FL; C: Relapsed / Refractory High Risk POD24 FL; D: Transformed FL
干预措施: None - Observational Study (Other)
结局指标
主要结局
To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.
时间窗: 5 years
The goal of this biomarker discovery registry is to assess DNA and RNA expression patterns and potential biomarkers in biospecimens collected at baseline and throughout treatment, with the goal of generating hypotheses about predictive markers for therapy selection, prognostic indicators, and potential mechanisms of resistance to standard-of-care therapies across multiple hematologic indications.
To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.
时间窗: 5 years
The goal of this biomarker discovery registry is to assess DNA and RNA expression patterns and potential biomarkers in biospecimens collected at baseline and throughout treatment, with the goal of generating hypotheses about predictive markers for therapy selection, prognostic indicators, and potential mechanisms of resistance to standard-of-care therapies across multiple hematologic indications.
次要结局
未报告次要终点