An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 20
- 主要终点
- Clinical response to treatment
研究概览
简要总结
This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.
详细描述
This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year.
The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Provide written informed consent;
- •Age ≥ 18 years, male or female, of any race;
- •Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy:
- •Acute myelogenous leukemia (AML)
- •Multiple myeloma (MM)
- •Myelodysplastic syndrome (MDS)
- •Acute lymphocytic leukemia (ALL)
- •Chronic lymphocytic leukemia (CLL)
- •Chronic myelogenous leukemia (CML)
- •Neoplasm (MPN)
- •Other (upon review and approval by medical monitor)
- •Note: *Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study
- •Intent to start anti-cancer therapy within 21 days of biospecimen collection
- •≥7 days from last anti-cancer therapy;
- •Any number of prior therapies
- •Subject cohort is currently open
排除标准
- •Unwilling or unable to give consent
- •Subject's disease is in remission
- •Subject cohort is not open at time of consent
- •Subject is restarting an ongoing treatment regimen after a dose interruption
结局指标
主要结局
Clinical response to treatment
时间窗: 3 years
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
次要结局
- Type of clinical treatment responses(3 years)
- Types of somatic tumor mutations(3 years)