Acute Myeloid LeukemiaCOLLECTNCT03148197
Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)
An observational study of Acute Myeloid Leukemia and Graft-versus-host-disease, run by University of Cologne at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Graft-versus-host-disease, Allogeneic Hematopoietic Stem Cell Transplantation
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: university hospital cologne
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, 50937
Maria Vehreschild, MD, +49 221 478 88794, maria.vehreschild@uk-koeln.de
About this study
Official title: 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.
Read the 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)
- Conditions
- Acute Myeloid Leukemia, Graft-versus-host-disease, Allogeneic Hematopoietic Stem Cell Transplantation, Stem Cell Transplant Complications
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Graft-versus-host-disease, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 365 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start14 Jul 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
- Investigators
- Maria Vehreschild, MD, Principal investigator, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148197
- Sponsor's protocol ID
- COLLECT
- Acronym
- COLLECT
- Status last verified
- Jul 2017
- First submitted
- 8 May 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24939656Jenq 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.
PubMed 25977230Weber 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.
PubMed 26209659
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes Over Time in the Gut Microbiota of High-risk Hematological Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)
- ClinicalTrials.gov ID
- NCT03148197
- Acronym / sponsor ID
- COLLECT / COLLECT
- Conditions
- Acute Myeloid Leukemia, Graft-versus-host-disease, Allogeneic Hematopoietic Stem Cell Transplantation, Stem Cell Transplant Complications
- Keywords
- Allogeneic hematopoietic stem cell transplantation, Graft-versus-host-disease, Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- university hospital cologne
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality
Time frame: 365 days
Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort
Time frame: 365 days
Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes
Time frame: 365 days
Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 24939656Taur 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.
- Background: PubMed 25977230Jenq 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.
- Background: PubMed 26209659Weber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Vehreschild, MD principal investigator
University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Graft-versus-host-disease, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Vehreschild, MD (+49 221 478 88794, maria.vehreschild@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.