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JOURNAL ONKOLOGIE – STUDIE
COLLECT

Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)

Rekrutierend

NCT-Nummer:
NCT03148197

Studienbeginn:
Juli 2017

Letztes Update:
19.07.2017

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Myeloid, Leukemia, Myeloid, Acute, Graft vs Host Disease

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

Maria Vehreschild, MD
Principal Investigator
University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Kontakt

Studienlocations
(1 von 1)

University Hospital of Cologne
50937 Cologne
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maria Vehreschild, MD
Phone: +49 221 478 88794
E-Mail: maria.vehreschild@uk-koeln.de
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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)

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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.

Studien-Arme

  • 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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