Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants

NCT ID: NCT00899327

Last Updated: 2009-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

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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

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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

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Leukemia Myelodysplastic Syndromes

Interventions

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DNA methylation analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

cytogenetic analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Vyas Paresh, MD

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

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Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Contact Person

Role: primary

44-1865-222-309

Other Identifiers

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MRC-MDS-BIO1

Identifier Type: -

Identifier Source: secondary_id

EU-20852

Identifier Type: -

Identifier Source: secondary_id

CDR0000595855

Identifier Type: -

Identifier Source: org_study_id

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