Fanconi AnemiaNCT00896740
Gene Function in Bone Marrow Cells From Patients With Fanconi Anemia and From Healthy Participants
An observational study of Fanconi Anemia, run by OHSU Knight Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fanconi Anemia
- What is being tested?
- microarray analysis and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells
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.
Read the 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.
- Conditions
- Fanconi Anemia
- Being tested
- microarray analysis, biopsy
- Keywords
- Fanconi anemia
- Medical subject headings
- Fanconi Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2002
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fanconi AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Grover Bagby, OHSU Knight Cancer Institute
- Investigators
- Grover C. Bagby, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896740
- Sponsor's protocol ID
- IRB00000713
- Other IDs
- OHSU-HEM-01079-L, CDR0000445212
- Status last verified
- Nov 2017
- First submitted
- 9 May 2009
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Fanconi Anemia Gene Function by Microarray Analysis of Bone Marrow Cells
- ClinicalTrials.gov ID
- NCT00896740
- Acronym / sponsor ID
- IRB00000713
- Conditions
- Fanconi Anemia
- Keywords
- Fanconi anemia
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 90 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microarray analysis | Genetic | – |
| biopsy | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grover C. Bagby, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fanconi Anemia, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Fanconi anemia (FA) hematopoietic cells vs normal hematopoietic cells. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.