Design of New Personalized Therapeutic Approaches for Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)
研究概览
简要总结
In Europe diffuse large B-cell lymphoma (DLBCL) is a rare disease whereas in Italy it is not. Approximately 40% of DLBCL patients has refractory disease or will relapse after initial response. In onco-hematology, a role for gut microbiota (GM) in mediating immune activation in response to chemotherapy, has been suggested. In this scenario, the Investigators hypothesized that GM could play an important role in DLBCL prognosis and response to treatment, establishing a connection between lifestyle and clinical response. The project is aimed to the study of the functional GM layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemo-immunotherapy. Results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.
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
- •Age ≥18 years
- •Patients affected by histologically confirmed diffuse large B-cell lymphoma
- •Patients amenable for therapy with RCHOP (RCHOP is the standard first line therapy for DLBCL and it scheduled regardless of participation in present study).
- •Patients must provide written informed consent.
排除标准
- •Concomitant second malignancy, other than lymphoma.
- •Previous anti-lymphoma therapy.
- •Pregnancy or breastfeeding.
- •Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
结局指标
主要结局
GM dysbiosis assessment (bacterial DNA of gut microbiota in all patients)
时间窗: 18 months
* dysbiosis index: the dysbiosis index relies on the calculation of the weighted ratio between health-promoting and disease-associated GM components * relative abundance of GM biomarkers of an eubiotic GM state: all GM dysbiotic states share a common feature, i.e. the depletion of strategic health-promoting GM components such as Faecalibacterium prausnitzii and Lachnospiraceae. Thus, a GM dysbiotic state is determined by the assessment of a reduction of the abundance of these GM biomarkers below the thresholds characteristic of an eubiotc GM state.
次要结局
- Response to therapy(2 years)
研究者
Pier Luigi Zinzani
Full Professor, MD (Hematologist)
University of Bologna