LeukemiaNCT00899327
Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants
An observational study of Leukemia and Myelodysplastic Syndromes, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- DNA methylation analysis, RNA analysis and cytogenetic analysis
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Dec 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Must meet 1 of the following criteria:
- Being investigated for a potential blood disorder due to abnormal blood count
- Patients with a known blood disorder who are having a bone marrow sample taken as part of the assessment of that disorder
- Patients undergoing hip replacement surgery at Nuffield Orthopaedic Centre, Oxford meeting the following criteria:
- Not on treatment likely to impair bone marrow function
- No history of having had treatment likely to have impaired bone marrow function
- Normal blood count
- Archived samples from patients with known blood disorder
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Contact Person, 44-1865-222-309, paresh.vyas@imm.ox.ac.uk
About this study
Official title: Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow.
PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.
Read the detailed description
OBJECTIVES:
Primary
- To identify novel biomarkers of disease that would help in the initial diagnosis of myelodysplastic syndromes (MDS).
Secondary
- To understand the genesis of anemia in cancers.
- To identify novel biomarkers of disease that predict progression of MDS to acute myeloid leukemia.
OUTLINE: Blood and bone marrow samples are collected. Hemopoietic stem cells (HSC) and progenitor cells are isolated from samples for analysis. Some of these HSC and progenitor cells are used for functional assays. From the rest of the cells, DNA, RNA, and protein is extracted for molecular analyses, including gene mutation analysis, gene methylation assays, chromatin immunoprecipitation, microarray, and real-time polymerase chain reaction.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- DNA methylation analysis, RNA analysis, cytogenetic analysis, gene expression analysis, mutation analysis
- Keywords
- myelodysplastic syndromes, acute myeloid leukemia
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
RNA analysisGenetic
cytogenetic analysisGenetic
gene expression analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of novel biomarkers of disease
Secondary outcomes (2)
Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia
Comprehension of genesis of anemia in cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Vyas Paresh, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899327
- Sponsor's protocol ID
- CDR0000595855
- Other IDs
- MRC-MDS-BIO1, EU-20852
- Status last verified
- Jul 2009
- First submitted
- 9 May 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis
- ClinicalTrials.gov ID
- NCT00899327
- Acronym / sponsor ID
- CDR0000595855
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- myelodysplastic syndromes, acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow.
PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.
Detailed description
OBJECTIVES:
Primary
- To identify novel biomarkers of disease that would help in the initial diagnosis of myelodysplastic syndromes (MDS).
Secondary
- To understand the genesis of anemia in cancers.
- To identify novel biomarkers of disease that predict progression of MDS to acute myeloid leukemia.
OUTLINE: Blood and bone marrow samples are collected. Hemopoietic stem cells (HSC) and progenitor cells are isolated from samples for analysis. Some of these HSC and progenitor cells are used for functional assays. From the rest of the cells, DNA, RNA, and protein is extracted for molecular analyses, including gene mutation analysis, gene methylation assays, chromatin immunoprecipitation, microarray, and real-time polymerase chain reaction.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DNA methylation analysis | Genetic | – |
| RNA analysis | Genetic | – |
| cytogenetic analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| protein expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of novel biomarkers of disease
2 secondary outcomes
Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia
Comprehension of genesis of anemia in cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
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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.
Vyas Paresh, MD principal investigator
Oxford University Hospitals NHS Trust
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 Leukemia and Myelodysplastic Syndromes, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Jul 2009. 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 Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of novel biomarkers of disease. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2009; AzTrials last refreshed its copy on 8 Nov 2026.