Gene Function in Bone Marrow Cells From Patients With Fanconi Anemia and From Healthy Participants

Fanconi Anemia Clinical Trial

Official title:

Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00896740
• Other study ID #: IRB00000713
• Secondary ID: OHSU-HEM-01079-L
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 30, 2017
• Start date: March 2002
• Est. completion date: September 2007

Study information

• Verified date: November 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying samples of bone marrow from patients with Fanconi anemia and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to Fanconi anemia.

PURPOSE: This laboratory study is evaluating gene function in bone marrow cells from patients with Fanconi anemia and from healthy participants.

Description:

OBJECTIVES:

• Describe the complete hematopoietic transcriptomes of Fanconi cells of every common complementation group (e.g., A, C, G, and F) as well as transcriptomes of neoplastic cells derived from bone marrow of patients with Fanconi anemia.

• Define large-scale dynamic gene expression data in these patients.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo bone marrow aspiration or biopsy for biological studies. Samples are analyzed for gene expression profiles using microarray assays.

PROJECTED ACCRUAL: A total of 80 patients and 10 healthy volunteers will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 55 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Diagnosis of Fanconi anemia

• Requires bone marrow aspiration or biopsy for clinical purposes

• Healthy volunteer

• Over 18 years of age

• No known blood abnormality

PATIENT CHARACTERISTICS:

• Platelet count > 150,000/mm^3

• White Blood Cell(WBC) > 4,000/mm^3

• Hemoglobin > 13 g/dL

• No clinical signs or symptoms of acute or subacute infection (e.g., viral, bacterial, or fungal)

• No allergies to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Anemia
• Fanconi Anemia
• Fanconi Syndrome

Intervention

Genetic:
• microarray analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells
Primary	Comparison of FA hematopoietic cells from children with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) vs children (siblings) with FA but without MDS/AML
Primary	Comparison of FA cells from different complementation groups