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:
- 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
1. Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD (Time Frame - 365 days): Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.
Secondary outcome:
1. Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality (Time Frame - 365 days): Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
2. Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort (Time Frame - 365 days): Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
3. Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes (Time Frame - 365 days): 3-indoxylsulfate (3-IS) concentration levels will be quantified using liquid chromatography in combination with mass spectrometry.
4. Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles (Time Frame - 365 days): Cytokine analysis will be performed on the collected plasma samples (citrate) using multiplex assays and read on a Luminex100™ platform.
Admitted for allogeneic HSCT Patients admitted for performance of an allogeneic HSCT after high dosis chemotherapy.
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.
Quelle: ClinicalTrials.gov
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"Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)"
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