MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project (Deciphering Immunopathogenesis of MUCORmycosis to ADVANCE Risk Stratification, Diagnosis and Management of the Disease)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
To collect data and samples from participants with cancer who also have invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection.
详细描述
Primary Objective:
To establish MD Anderson Mucormycosis Clinical Core for the MUCOR-ADVANCE P01 Project.
- To prospectively identify, collect, and store all isolates causing proven or probable MCM in adult high-risk cancer participants.
- To prospectively identify, collect, and store relevant host samples from high-risk participants developing proven or probable MCM, along with relevant biospecimens from three control groups.
- To comprehensively annotate clinical specimens and provide information regarding the course and outcome of all MCM cases and controls.
OUTLINE:
This is an observational study. Patients are assigned to 1 of 4 groups.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18-100 years old and have cancer and invasive mucormycosis, invasive aspergillosis, bacterial pneumonia, or a risk for fungal infection but no evidence of such infection.
- •Patients must be willing to undergo routine diagnostic procedures (e.g., phlebotomy, bronchoscopy, biopsy) as part of their regular care.
排除标准
- •Patients who are unwilling to undergo routine diagnostic procedures as part of their regular care.
研究组 & 干预措施
Group A
Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.
干预措施: Mucormycosis (Behavioral)
Group B
Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.
干预措施: Mucormycosis (Behavioral)
Group C
Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.
干预措施: Mucormycosis (Behavioral)
Group M
Patients with mucormycosis undergo collection of blood, tissue and BAL fluid samples as well as have their medical records reviewed on study.
干预措施: Mucormycosis (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
次要结局
未报告次要终点