Prospective, Observational, Multi-centred, Non-interventional Research Project on Plasma Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Tumor Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Accuracy of interim plasma cell free DNA genotyping for MCL patients
研究概览
简要总结
The study aims at assessing whether cell free DNA genotyping can improve the accuracy of early prediction of cure in mature B-cell tumor patients and whether it represents an accessible source of tumor DNA for the sensitive identification of genetic biomarkers that refine the diagnostic workup, stratify prognosis and identify the emergence of drug-resistance mutations during treatment.
详细描述
Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of mature B-cell tumor diagnosis, before treatment, at the time of interim PET/CT, at the time of end of treatment PET/CT and at the time of disease relapse.
Clinical variables, international prognostic index, results of plasma cell free DNA genotyping and of PET-CT will be analyzed descriptively.
The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the compiled results of plasma cell free DNA genotyping and interim PET-CT (for cHL and DLBCL), or plasma cell free DNA genotyping and baseline international prognostic index (for FL and MCL) in identifying patients that are progression free for >24 months after first line therapy will be calculated and compared with those obtained by the sole interim PET-CT (cHL and DLBCL) or the sole international prognostic index (FL, MCL).
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
- •Male or female adults 18 years or older
- •Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
- •Willing and able to comply with scheduled study procedures
- •Evidence of a signed informed consent
排除标准
- 未提供
结局指标
主要结局
Accuracy of interim plasma cell free DNA genotyping for MCL patients
时间窗: 24 months from treatment
Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in MCL
Accuracy of interim plasma cell free DNA genotyping for cHL patients
时间窗: 24 months from treatment
Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in cHL (patients not progressed after 24 months)
Accuracy of interim plasma cell free DNA genotyping for FL patients
时间窗: 24 months from treatment
Assessment of interim plasma cell free DNA genotyping accuracy in the identification of patients in continuous complete remission at 24 months from first line treatment vs patients not in continuous complete remission at 24 months from first line treatment in FL and other indolent B-cell lymphoproliferative disorders
Accuracy of interim plasma cell free DNA genotyping for DLBCL patients
时间窗: 24 months from treatment
Assessment of interim plasma cell free DNA genotyping accuracy in the identification of cured vs non cured patients in DLBCL (patients not progressed after 24 months)
次要结局
未报告次要终点
研究者
Davide Rossi
MD, PhD
Oncology Institute of Southern Switzerland