Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT) (COLLECT)
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.
연구 개요
상태
상세 설명
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)
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Cologne, 독일, 50937
- 모병
- University Hospital of Cologne
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연락하다:
- Maria Vehreschild, MD
- 전화번호: +49 221 478 88794
- 이메일: maria.vehreschild@uk-koeln.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Admitted for allogeneic HSCT
Patients admitted for performance of an allogeneic HSCT after high dosis chemotherapy.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD
기간: 365 days
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Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.
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365 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality
기간: 365 days
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Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
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365 days
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Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort
기간: 365 days
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Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.
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365 days
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Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes
기간: 365 days
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3-indoxylsulfate (3-IS) concentration levels will be quantified using liquid chromatography in combination with mass spectrometry.
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365 days
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Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles
기간: 365 days
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Cytokine analysis will be performed on the collected plasma samples (citrate) using multiplex assays and read on a Luminex100™ platform.
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365 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Vehreschild, MD, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- COLLECT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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