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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899327
First Posted: May 12, 2009
Last Update Posted: July 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
Leukemia Myelodysplastic Syndromes 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

Study Type: Observational
Official Title: Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of novel biomarkers of disease

Secondary Outcome Measures:
  • Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia
  • Comprehension of genesis of anemia in cancer

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899327


Locations
United Kingdom
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Contact Person    44-1865-222-309    paresh.vyas@imm.ox.ac.uk   
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Vyas Paresh, MD Oxford University Hospitals NHS Trust
  More Information

ClinicalTrials.gov Identifier: NCT00899327     History of Changes
Other Study ID Numbers: CDR0000595855
MRC-MDS-BIO1
EU-20852
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
myelodysplastic syndromes
acute myeloid leukemia

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms