Acute GVH DiseaseNCT02917148
MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
An observational study of Acute GVH Disease, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute GVH Disease
- What is being tested?
- Peripheral Venipuncture or Blood draw from Central Line
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients included in the study will be patients undergoing allogeneic transplantation, and some will suffer from aGVHD and some will not.
Who may be able to join
- Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age
- Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6)
- Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant
- Patients who develop grade II-IV aGVHD
Who cannot join
- Patients who receive transplants from incompletely matched donors
- Patients who receive T cell depleted transplants
- Patients who receive haplo-identical transplants
- Pregnant Patients
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.
Read the detailed description
Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.
All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.
- Conditions
- Acute GVH Disease
- Being tested
- Peripheral Venipuncture or Blood draw from Central Line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Venipuncture or Blood draw from Central LineOther
Also called Venipuncture, Blood Draw
| Study group | Role | What they receive |
|---|---|---|
| aGVHD | Patient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant. Receives: Other: Peripheral Venipuncture or Blood draw from Central Line | |
| non aGVHD | Patients who undergo allogeneic transplant but do not develop aGVHD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute GVH DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Mensah, Northwell Health
- Investigators
- Cheryl Mensah, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917148
- Sponsor's protocol ID
- 15-229
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11.
PubMed 19282026Paczesny S. Discovery and validation of graft-versus-host disease biomarkers. Blood. 2013 Jan 24;121(4):585-94. doi: 10.1182/blood-2012-08-355990. Epub 2012 Nov 19.
PubMed 23165480Xiao B, Wang Y, Li W, Baker M, Guo J, Corbet K, Tsalik EL, Li QJ, Palmer SM, Woods CW, Li Z, Chao NJ, He YW. Plasma microRNA signature as a noninvasive biomarker for acute graft-versus-host disease. Blood. 2013 Nov 7;122(19):3365-75. doi: 10.1182/blood-2013-06-510586. Epub 2013 Sep 16.
PubMed 24041574Xie LN, Zhou F, Liu XM, Fang Y, Yu Z, Song NX, Kong FS. Serum microRNA155 is increased in patients with acute graft-versus-host disease. Clin Transplant. 2014 Mar;28(3):314-23. doi: 10.1111/ctr.12314. Epub 2014 Feb 4.
PubMed 24494749
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT02917148
- Acronym / sponsor ID
- 15-229
- Conditions
- Acute GVH Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- 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.
The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.
Detailed description
Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.
All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aGVHD | – | Other: Peripheral Venipuncture or Blood draw from Central LinePatient who undergo allogeneic transplant with clinical and/or biopsy-proven diagnosis of aGVHD within the first 100 days post-transplant. |
| non aGVHD | – | –Patients who undergo allogeneic transplant but do not develop aGVHD. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients included in the study will be patients undergoing allogeneic transplantation, and some will suffer from aGVHD and some will not.
Key inclusion criteria (4 listed)
- Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age
- Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6)
- Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant
- Patients who develop grade II-IV aGVHD
Key exclusion criteria (4 listed)
- Patients who receive transplants from incompletely matched donors
- Patients who receive T cell depleted transplants
- Patients who receive haplo-identical transplants
- Pregnant Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Venipuncture or Blood draw from Central LineAlso: Venipuncture, Blood Draw | Other | aGVHD |
Primary outcome
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Results publication: PubMed 19282026Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet. 2009 May 2;373(9674):1550-61. doi: 10.1016/S0140-6736(09)60237-3. Epub 2009 Mar 11.
- Results publication: PubMed 23165480Paczesny S. Discovery and validation of graft-versus-host disease biomarkers. Blood. 2013 Jan 24;121(4):585-94. doi: 10.1182/blood-2012-08-355990. Epub 2012 Nov 19.
- Results publication: PubMed 24041574Xiao B, Wang Y, Li W, Baker M, Guo J, Corbet K, Tsalik EL, Li QJ, Palmer SM, Woods CW, Li Z, Chao NJ, He YW. Plasma microRNA signature as a noninvasive biomarker for acute graft-versus-host disease. Blood. 2013 Nov 7;122(19):3365-75. doi: 10.1182/blood-2013-06-510586. Epub 2013 Sep 16.
- Results publication: PubMed 24494749Xie LN, Zhou F, Liu XM, Fang Y, Yu Z, Song NX, Kong FS. Serum microRNA155 is increased in patients with acute graft-versus-host disease. Clin Transplant. 2014 Mar;28(3):314-23. doi: 10.1111/ctr.12314. Epub 2014 Feb 4.
- 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.
Cheryl Mensah, MD principal investigator
Northwell Health
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 GVH Disease, run by Northwell Health at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 Oct 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls. (time frame: 24 months). 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 NCT02917148, which also lists 4 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 11 Oct 2017.