Changes Over Time in the Gut Microbiota of High-risk Hematological Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD
研究概览
简要总结
COLLECT is a monocentric, prospective, observational study, which aims to assess the association between changes in the intestinal microbiota and the incidence of gastrointestinal graft-versus-host diseases (GvHD). Patients admitted for performance of an allogeneic hematopoietic stem cell transplantation (HSCT) or patients with a first diagnosis of an acute myeloid leukemia (AML) will be enrolled and stool samples will be analyzed using next-generation sequencing. In addition to stool, blood and urine samples will be collected for cytokine and 3-indoxylsulfate analysis.
Exposure to drugs will not be influenced and remains at the discretion of the treating physician.
详细描述
Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.
The following data items of patients with a written informed consent are prospectively documented into our database:
- Demographics
- Chemotherapeutic agents
- Other immunosuppressives
- Radiation treatment
- Antibiotic prophylaxis and treatment
- Bowel movement abnormalities
- HSCT Donor and recipient information
- Status of hematological disease
- Days with neutropenia
- Fever and infectious complications
The following samples of patients with a written informed consent are prospectively collected, stored and analyzed:
- Stool samples (16S rRNA analysis)
- Urine (3-IS analysis)
- Ethylenediaminetetraacetic acid (EDTA) blood samples (PBMCs Fluorescence-activated cell sorting (FACS) analysis)
- Citrate blood samples (cytokine analysis)
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 of at least 18 years
- •Patients admitted for performance of an allogeneic HSCT OR
- •Patients with a first diagnosis of an acute myeloid leukemia
- •No contraindication for an allogeneic stem cell transplantation
- •Subject is not legally incapacitated
- •Written informed consent from the study subject has been obtained
排除标准
- •Active inflammatory bowel disease
- •Ongoing gastroenteritis at the time of inclusion
- •Patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study
- •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •Persons held in an institution by legal or official order
结局指标
主要结局
Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD
时间窗: 365 days
Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.
次要结局
- Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles(365 days)
- Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality(365 days)
- Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort(365 days)
- Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes(365 days)
研究者
Maria J.G.T. Vehreschild
PD MD
University of Cologne