Bone CancerNCT00160719
HLA Sensitization Following Major Cortical Allograft Bone Procedures
An observational study of Bone Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Bone Cancer
- What is being tested?
- retrieve blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Mar 2010
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopaedic clinic
Who may be able to join
- Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces.
Who cannot join
- Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32611
About this study
The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.
Read the detailed description
Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.
- Conditions
- Bone Cancer
- Being tested
- retrieve blood samples
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrieve blood samplesProcedure or surgery
blood samples obtain pre-op, 6 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 1999
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark T. Scarborough, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160719
- Sponsor's protocol ID
- 173-2005
- Status last verified
- Oct 2012
- First submitted
- 8 Sep 2005
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA Sensitization Following Major Cortical Allograft Bone Procedures
- ClinicalTrials.gov ID
- NCT00160719
- Acronym / sponsor ID
- 173-2005
- Conditions
- Bone Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.
Detailed description
Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic clinic
Key inclusion criteria (1 listed)
- Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces.
Key exclusion criteria (1 listed)
- Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.
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 |
|---|---|---|
| retrieve blood samplesblood samples obtain pre-op, 6 and 12 months post-op | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 Oct 2012.
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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.
Mark T. Scarborough, M.D. principal investigator
University of Florida
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 Bone Cancer, run by University of Florida 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 30 Oct 2012. 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.
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 30 Oct 2012.