Acute Myeloid Leukemia Clinical Trial
Official title:
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.
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)
;
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