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)
Study Type
OBSERVATIONAL
Enrollment
120
University Hospital of Cologne
Cologne, Germany
RECRUITINGAssessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD
Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.
Time frame: 365 days
Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality
Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
Time frame: 365 days
Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort
Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
Time frame: 365 days
Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes
3-indoxylsulfate (3-IS) concentration levels will be quantified using liquid chromatography in combination with mass spectrometry.
Time frame: 365 days
Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles
Cytokine analysis will be performed on the collected plasma samples (citrate) using multiplex assays and read on a Luminex100™ platform.
Time frame: 365 days
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