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

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00896740
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 90
• Location: 1
• Duration (Months): 66
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fanconi Anemia	Genetic: microarray analysis; Procedure: biopsy

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells []

2. Comparison of FA hematopoietic cells from children with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) vs children (siblings) with FA but without MDS/AML []

3. Comparison of FA cells from different complementation groups []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Grover C. Bagby, MD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grover Bagby, Professor Emeritus, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT00896740
• Other Study ID Numbers: IRB00000713; OHSU-HEM-01079-L; CDR0000445212
• First Posted: May 12, 2009
• Last Update Posted: Dec 4, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Grover Bagby, Professor Emeritus, OHSU Knight Cancer Institute: Fanconi anemia
• Additional relevant MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia

Study Results

No Results Posted as of Dec 4, 2017