NCT03569137Unknown不适用
Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
研究概览
简要总结
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology
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
- •Outside the context of guardianship, -affiliated to the Social Security Regime and
- •Having consented to participate in the COLMI study.
- •Patient who benefit of treatment by targeted therapy to Ibrutinib
排除标准
- •History of uncontrolled colitis before the start of treatment.
- •Patient with inflammatory bowel disease.
- •Patient not consenting to participate.
结局指标
主要结局
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
时间窗: At the end of the study, after 2 years.
With the different species and metabolites between the 2 groups of patients (patients developing diarrhea after exposure to Ibrutinib and those not developing diarrhea), we will create a risk score for occurrence of diarrhea during treatment with Ibrutinib, on the previously developed model (Montassier et al, 2016, Genome medicine)
次要结局
- Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient(At the end of the study, after 2 years.)
- Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B.(At the end of the study, after 2 years.)
- Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule(At the end of the study, after 2 years.)
研究者
研究点 (1)
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