Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT) (COLLECT)
Changes Over Time in the Gut Microbiota of High-risk Hematological Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)
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.
研究概览
地位
详细说明
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)
研究类型
注册 (预期的)
联系人和位置
学习地点
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Cologne、德国、50937
- 招聘中
- University Hospital of Cologne
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接触：
- Maria Vehreschild, MD
- 电话号码：+49 221 478 88794
- 邮箱：maria.vehreschild@uk-koeln.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Admitted for allogeneic HSCT
Patients admitted for performance of an allogeneic HSCT after high dosis chemotherapy.
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First diagnosis AML
Patients admitted with a first diagnosis of an acute myeloid leukemia for chemotherapy.
Depending on factors like age or molecular risk profile some of these patients will proceed to allogeneic HSCT.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD
大体时间：365 days
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Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.
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365 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality
大体时间：365 days
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Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
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365 days
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Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort
大体时间：365 days
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Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
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365 days
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Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes
大体时间：365 days
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3-indoxylsulfate (3-IS) concentration levels will be quantified using liquid chromatography in combination with mass spectrometry.
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365 days
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Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles
大体时间：365 days
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Cytokine analysis will be performed on the collected plasma samples (citrate) using multiplex assays and read on a Luminex100™ platform.
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365 days
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合作者和调查者
调查人员
- 首席研究员：Maria Vehreschild, MD、University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
出版物和有用的链接
一般刊物
- Taur Y, Jenq RR, Perales MA, Littmann ER, Morjaria S, Ling L, No D, Gobourne A, Viale A, Dahi PB, Ponce DM, Barker JN, Giralt S, van den Brink M, Pamer EG. The effects of intestinal tract bacterial diversity on mortality following allogeneic hematopoietic stem cell transplantation. Blood. 2014 Aug 14;124(7):1174-82. doi: 10.1182/blood-2014-02-554725. Epub 2014 Jun 17.
- Jenq RR, Taur Y, Devlin SM, Ponce DM, Goldberg JD, Ahr KF, Littmann ER, Ling L, Gobourne AC, Miller LC, Docampo MD, Peled JU, Arpaia N, Cross JR, Peets TK, Lumish MA, Shono Y, Dudakov JA, Poeck H, Hanash AM, Barker JN, Perales MA, Giralt SA, Pamer EG, van den Brink MR. Intestinal Blautia Is Associated with Reduced Death from Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2015 Aug;21(8):1373-83. doi: 10.1016/j.bbmt.2015.04.016. Epub 2015 May 11.
- Weber D, Oefner PJ, Hiergeist A, Koestler J, Gessner A, Weber M, Hahn J, Wolff D, Stammler F, Spang R, Herr W, Dettmer K, Holler E. Low urinary indoxyl sulfate levels early after transplantation reflect a disrupted microbiome and are associated with poor outcome. Blood. 2015 Oct 1;126(14):1723-8. doi: 10.1182/blood-2015-04-638858. Epub 2015 Jul 24.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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