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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00896740
First received: May 9, 2009
Last updated: November 20, 2012
Last verified: October 2007
  Purpose

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 Intervention
Fanconi Anemia
Genetic: microarray analysis
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells [ Designated as safety issue: No ]
  • Comparison of FA hematopoietic cells from children with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) vs children (siblings) with FA but without MDS/AML [ Designated as safety issue: No ]
  • Comparison of FA cells from different complementation groups [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: March 2002
Study Completion Date: September 2007
Estimated Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   1 Year to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896740

Locations
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Grover C. Bagby, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00896740     History of Changes
Other Study ID Numbers: CDR0000445212, OHSU-HEM-01079-L, IRB00000713
Study First Received: May 9, 2009
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
Fanconi anemia

Additional relevant MeSH terms:
Anemia
Fanconi Anemia
Fanconi Syndrome
Hematologic Diseases
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Bone Marrow Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Tubular Transport, Inborn Errors
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on September 18, 2014