Multi-center MRD Registry for Inflammatory Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
研究概览
简要总结
To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.
详细描述
Primary Objectives
-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).
Secondary Objectives
- To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.
- To evaluate the association of pre-surgery MRD to pathologic response.
- To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results
- To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally
- To determine the median lead time between the first MRD-positive result and clinical recurrence.
- To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.
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
- •Female or males ≥18 years of age with the ability to understand and sign a written
- •Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).
- •Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.
- •Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.
- •Participants must be English-speaking.
排除标准
- 未提供
研究组 & 干预措施
Group 1
Participants will fill out a quality-of-life questionnaire and complete a MRD test.
干预措施: Quality-of-life Questionnaire (Behavioral)
结局指标
主要结局
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
时间窗: Through study completion; an average of 1 year
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Score scale: (1-30 questions to assess the impact of participants quality of life)
次要结局
未报告次要终点