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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:
The following samples of patients with a written informed consent are prospectively collected, stored and analyzed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment 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. | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 365 days |
| Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort |
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Inclusion Criteria:
Exclusion Criteria:
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university hospital cologne
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Vehreschild, MD | Contact | +49 221 478 88794 | maria.vehreschild@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Maria Vehreschild, MD | University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Recruiting | Cologne | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24939656 | Background | 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. | |
| 25977230 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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PBMCs, plasma, urine and stool samples, retention until analysis
Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity. |
| 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. | 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. | 365 days |
| Background |
| 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. |
| 26209659 | Background | 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |