Exostoses, Multiple HereditaryNCT00473850
Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC
An observational study of Exostoses, Multiple Hereditary, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to establish the genetic profile of families in British Columbia with HME. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exostoses, Multiple Hereditary
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- Dec 1998to Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Benetic profile of families in British Columbia with HME.
Who may be able to join
- Diagnosed with HME
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the genetic profile of families in British Columbia with HME.
Read the detailed description
The purpose of this study is to establish the genetic make-up of families and patients with HME. This will occur as the patient presents to a regular clinic visit. Dr. Alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. If the patient and their direct family are interested they will be entered into the study. This will involve interviewing the patients and their direct family. This interview will take about 1 hour. We are interested in identifying all affected family members as far up the family tree as possible. We ask that the idea of the study be introduced to extended family members by the participating family members and then have them call Dr. Alvarez to set up an appointment. Each available member will be interviewed and a physical exam done to determine the location of osteochondromas. In addition, Xrays will be done to determine the location of all osteochondromas. All Xrays will be reviewed. No new ones will be taken unless it is part of the patient's routine care.
To complete the genetic work up DNA analysis will be done on all available family members. This will entail obtaining a blood sample from each family member willing to partake in the study. These blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. The blood samples will be taken at British Columbia's Children's Hospital and processed there. DNA samples will be kept confidential.
- Conditions
- Exostoses, Multiple Hereditary
- Keywords
- DNA sequencing, EXT genes, Hereditary Multiple Exostoses,, also known as Multiple Hereditary Exostoses,, also known as Hereditary Multiple Osteochondromas
- Medical subject headings
- Exostoses, Multiple Hereditary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startDec 1998
- Study completionMar 2023 (estimated)
Why it stopped: This study is recruiting under a different title - "Genotype-Phenotype Correlation of Multiple Hereditary Exostoses: Multicentre Project" NCT00474331
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exostoses, Multiple HereditaryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Circle of Care, Vancouver Foundation, Children's & Women's Health Centre of British Columbia
- Investigators
- Christine Alvarez, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473850
- Sponsor's protocol ID
- H98-70441
- Status last verified
- Apr 2011
- First submitted
- 14 May 2007
- Last updated
- 15 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC
- ClinicalTrials.gov ID
- NCT00473850
- Acronym / sponsor ID
- H98-70441
- Conditions
- Exostoses, Multiple Hereditary
- Keywords
- DNA sequencing, EXT genes, Hereditary Multiple Exostoses,, also known as Multiple Hereditary Exostoses,, also known as Hereditary Multiple Osteochondromas
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study is recruiting under a different title - "Genotype-Phenotype Correlation of Multiple Hereditary Exostoses: Multicentre Project" NCT00474331
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Circle of Care, Vancouver Foundation, Children's & Women's Health Centre of British Columbia
- Study start
- Dec 1998
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 May 2007 (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 establish the genetic profile of families in British Columbia with HME.
Detailed description
The purpose of this study is to establish the genetic make-up of families and patients with HME. This will occur as the patient presents to a regular clinic visit. Dr. Alvarez will be introduced to interested patients and their parent(s) and a brief discussion about the project will occur. If the patient and their direct family are interested they will be entered into the study. This will involve interviewing the patients and their direct family. This interview will take about 1 hour. We are interested in identifying all affected family members as far up the family tree as possible. We ask that the idea of the study be introduced to extended family members by the participating family members and then have them call Dr. Alvarez to set up an appointment. Each available member will be interviewed and a physical exam done to determine the location of osteochondromas. In addition, Xrays will be done to determine the location of all osteochondromas. All Xrays will be reviewed. No new ones will be taken unless it is part of the patient's routine care.
To complete the genetic work up DNA analysis will be done on all available family members. This will entail obtaining a blood sample from each family member willing to partake in the study. These blood samples will be used only for the purpose of identifying abnormalities in the genes related to osteochondromas. The blood samples will be taken at British Columbia's Children's Hospital and processed there. DNA samples will be kept confidential.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Benetic profile of families in British Columbia with HME.
Key inclusion criteria (1 listed)
- Diagnosed with HME
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: This study is recruiting under a different title - "Genotype-Phenotype Correlation of Multiple Hereditary Exostoses: Multicentre Project" NCT00474331). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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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.
Christine Alvarez, MD principal investigator
University of British Columbia
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 Exostoses, Multiple Hereditary, run by University of British Columbia at 1 site in Canada.
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 0 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: stopped early, as of the sponsor's last update on 15 Apr 2011. 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 Canada. 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 (reason given: This study is recruiting under a different title - "Genotype-Phenotype Correlation of Multiple Hereditary Exostoses: Multicentre Project" NCT00474331). 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.
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 15 Apr 2011.