NCT00899327

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

4.9 years

First QC Date

May 9, 2009

Last Update Submit

July 7, 2009

Conditions

Keywords

myelodysplastic syndromesacute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Identification of novel biomarkers of disease

Secondary Outcomes (2)

  • Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia

  • Comprehension of genesis of anemia in cancer

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

DNA MethylationCytogenetic AnalysisGene Expression ProfilingPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesNucleic Acid Amplification Techniques

Study Officials

  • Vyas Paresh, MD

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations