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

Leukemia Clinical Trial

Official title:

Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899327
• Other study ID #: CDR0000595855
• Secondary ID: MRC-MDS-BIO1EU-2
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 7, 2009
• Start date: January 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Genetic:
• DNA methylation analysis

• RNA analysis

• cytogenetic analysis

• gene expression analysis

• mutation analysis

• polymerase chain reaction

• protein expression analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Oxford Radcliffe Hospital	Oxford	England

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of novel biomarkers of disease			No
Secondary	Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia			No
Secondary	Comprehension of genesis of anemia in cancer			No