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

Sponsor
Oxford University Hospitals NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT00899327
Collaborator
(none)
200
1

Study Details

Study Description

Brief 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.

PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.

Condition or Disease Intervention/Treatment Phase
  • Genetic: DNA methylation analysis
  • Genetic: RNA analysis
  • Genetic: cytogenetic analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: protein expression analysis
  • Other: laboratory biomarker analysis

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Official Title:
Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis
Study Start Date :
Jan 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Identification of novel biomarkers of disease []

Secondary Outcome Measures

  1. Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia []

  2. Comprehension of genesis of anemia in cancer []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oxford Radcliffe Hospital Oxford England United Kingdom 0X3 9DU

Sponsors and Collaborators

  • Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Vyas Paresh, MD, Oxford University Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00899327
Other Study ID Numbers:
  • CDR0000595855
  • MRC-MDS-BIO1
  • EU-20852
First Posted:
May 12, 2009
Last Update Posted:
Jul 8, 2009
Last Verified:
Jul 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2009