Fanconi AnemiaNCT00899522
Tissue Sample Collection From Patients With Fanconi Anemia
An observational study of Fanconi Anemia and Unspecified Adult Solid Tumor, Protocol Specific, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia to test in the laboratory may help the study of cancer in the future. PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia. Read more about this study
- Who is it for?
- Ages 1 year to 55 years
- Conditions the study is for
- Fanconi Anemia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- biologic sample preservation procedure and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2013
- 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
- No healthy volunteers
- Child, Adult
Study population: To recruit participants into this project, an announcement will be posted on the Fanconi Anemia Research Fund website (http://www.fanconi.org/) after IRB approval is obtained.
DISEASE CHARACTERISTICS:
- Confirmed Fanconi anemia
- Confirmed malignant solid tumor
- Biopsy of tumor tissue available
PATIENT CHARACTERISTICS:
- Not specified
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: Fanconi Anemia Cancer Cell Repository
RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia.
Read the detailed description
OBJECTIVES:
- Acquire rare solid tumor samples from patients with Fanconi anemia in order to create a Fanconi Anemia Cell Repository at the Oregon Health and Science University Cancer Institute.
- Study repository tissue using a variety of molecular methods, including gene microarrays.
- Develop cancer cell lines that are publicly available from tissue archived from patients with Fanconi anemia.
OUTLINE: Tumor biopsies are collected from patients with Fanconi anemia and archived for future molecular studies, cell line generation, and general usage by the research community at large. Medical information about the patient's cancer is also archived.
PROJECTED ACCRUAL: Not specified.
- Conditions
- Fanconi Anemia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- biologic sample preservation procedure, biopsy
- Keywords
- Fanconi anemia, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
- Medical subject headings
- Fanconi Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
Once the pathologist has taken the material needed to establish diagnosis of cancer, the anonymized snap-frozen and fresh samples will be either shipped to our laboratory for analysis or will be picked up by a member of the principal investigator's lab team. Samples will be stored indefinitely.
biopsyProcedure or surgery
Once the pathologist has taken the material needed to establish diagnosis of cancer, 1-10 grams of the remaining tissue should be placed in phosphate buffered saline and shipped to the Bagby Lab.
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a Fanconi Anemia Cell Repository using rare solid tumor samples from patients with Fanconi anemia
Measured: Duration of the study
Study tissue samples by molecular methods, including gene microarrays
Measured: Duration of the study
Development of cancer cell lines from tissue archived from patients with Fanconi anemia
Measured: Duration of the study
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 startAug 2005
- Primary completionMar 2013
- Study completionMay 2013
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
- Retrospective
- Enrolment
- 8 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
- NCT00899522
- Sponsor's protocol ID
- IRB00001100
- Other IDs
- P30CA069533, OHSU-HEM-03022-LX, OHSU-IRB00001100, OSHU-CR00003822, CDR0000445453
- Status last verified
- Nov 2017
- First submitted
- 9 May 2009
- Last updated
- 4 Dec 2017
- Results posted
- No
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
- Fanconi Anemia Cancer Cell Repository
- ClinicalTrials.gov ID
- NCT00899522
- Acronym / sponsor ID
- IRB00001100
- Conditions
- Fanconi Anemia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- Fanconi anemia, unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (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: Collecting and storing samples of tumor tissue from patients with Fanconi anemia to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia.
Detailed description
OBJECTIVES:
- Acquire rare solid tumor samples from patients with Fanconi anemia in order to create a Fanconi Anemia Cell Repository at the Oregon Health and Science University Cancer Institute.
- Study repository tissue using a variety of molecular methods, including gene microarrays.
- Develop cancer cell lines that are publicly available from tissue archived from patients with Fanconi anemia.
OUTLINE: Tumor biopsies are collected from patients with Fanconi anemia and archived for future molecular studies, cell line generation, and general usage by the research community at large. Medical information about the patient's cancer is also archived.
PROJECTED ACCRUAL: Not specified.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- To recruit participants into this project, an announcement will be posted on the Fanconi Anemia Research Fund website (http://www.fanconi.org/) after IRB approval is obtained.
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 |
|---|---|---|
| biologic sample preservation procedureOnce the pathologist has taken the material needed to establish diagnosis of cancer, the anonymized snap-frozen and fresh samples will be either shipped to our laboratory for analysis or will be picked up by a member of the principal investigator's lab team. Samples will be stored indefinitely. | Other | – |
| biopsyOnce the pathologist has taken the material needed to establish diagnosis of cancer, 1-10 grams of the remaining tissue should be placed in phosphate buffered saline and shipped to the Bagby Lab. | Procedure or surgery | – |
Primary outcome
Creation of a Fanconi Anemia Cell Repository using rare solid tumor samples from patients with Fanconi anemia
Time frame: Duration of the study
Study tissue samples by molecular methods, including gene microarrays
Time frame: Duration of the study
Development of cancer cell lines from tissue archived from patients with Fanconi anemia
Time frame: Duration of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and Unspecified Adult Solid Tumor, Protocol Specific, 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Creation of a Fanconi Anemia Cell Repository using rare solid tumor samples from patients with Fanconi anemia (time frame: Duration of the study). 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.