Clinical trial NCT00896740: Gene Function in Bone Marrow Cells From Patients With Fanconi Anemia and From Healthy Participants
Official title: Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fanconi Anemia
Keywords: Fanconi anemia
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FA Patients are recruited from OHSU Clinics. Healthy Normal donors are recruited with an IRB approved advertisement which runs in the Outlook and is posted on bulletin boards around campus

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells
measure: Comparison of FA hematopoietic cells from children with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) vs children (siblings) with FA but without MDS/AML
measure: Comparison of FA cells from different complementation groups
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Knight Cancer Institute at Oregon Health and Science University
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Grover C. Bagby, MD
role: PRINCIPAL_INVESTIGATOR
References: