NCT00896740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

5.5 years

First QC Date

May 9, 2009

Last Update Submit

November 30, 2017

Conditions

Keywords

Fanconi anemia

Outcome Measures

Primary Outcomes (3)

  • Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells

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

  • Comparison of FA cells from different complementation groups

Interventions

Eligibility Criteria

Age1 Year - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Fanconi Anemia

Interventions

Microarray AnalysisBiopsy

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, CongenitalAnemia, AplasticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesCongenital Bone Marrow Failure SyndromesBone Marrow Failure DisordersBone Marrow DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Grover C. Bagby, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

March 1, 2002

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

December 4, 2017

Record last verified: 2017-11

Locations