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

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
DNA methylation analysis
RNA analysis
cytogenetic analysis
gene expression analysis
mutation analysis
polymerase chain reaction
protein expression analysis
laboratory biomarker analysis
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Leukemia focused on measuring myelodysplastic syndromes, acute myeloid leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oxford Radcliffe HospitalRecruiting

Outcomes

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

Full Information

First Posted
May 9, 2009
Last Updated
July 7, 2009
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00899327
Brief Title
Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants
Official Title
Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis
Study Type
Observational

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
myelodysplastic syndromes, acute myeloid leukemia

7. Study Design

Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA methylation analysis
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Type
Genetic
Intervention Name(s)
cytogenetic analysis
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Identification of novel biomarkers of disease
Secondary Outcome Measure Information:
Title
Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia
Title
Comprehension of genesis of anemia in cancer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyas Paresh, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1865-222-309
Email
paresh.vyas@imm.ox.ac.uk

12. IPD Sharing Statement

Learn more about this trial

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

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