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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899327
First received: May 9, 2009
Last updated: July 7, 2009
Last verified: July 2009
  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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia [ Designated as safety issue: No ]
  • Comprehension of genesis of anemia in cancer [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899327     History of Changes
Other Study ID Numbers: CDR0000595855, MRC-MDS-BIO1, EU-20852
Study First Received: May 9, 2009
Last Updated: July 7, 2009
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 22, 2014