- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00474448
The Health-Related Quality of Life in Patients With Hereditary Multiple Exostoses
May 16, 2022 updated by: Christine Alvarez, University of British Columbia
The purpose of this study is to assess the health-related quality of life of subjects who have Hereditary Multiple Exostoses and to develop a disease specific quality of life survey.
The investigators hypothesize that there are a wide range of quality of life experiences for patients with this syndrome.
Study Overview
Status
Completed
Conditions
Detailed Description
At the time of recruitment, subjects will be asked to indicate whether they would like to participate in a one-time survey, or are willing to participate in the initial survey plus two additional questionnaire administrations, thereafter, which will be used to develop the disease-specific quality of life (QOL) score.
All participants will complete either the SF-36 survey (for adult HME subjects) or the CHQ PF (for parents of children with HME), as applicable, in addition to a blank form with categorical subheadings (such as recreation, social function, etc.), which they will use to address any issues not covered in the standardized questionnaire.
Standardized questionnaires will be scored and analyzed.
The items listed on the second form will be compiled and reapplied to subjects that indicated interest in extended participation in survey completion.
Subjects will be asked to determine which items apply to them and to rank these applicable items in order of importance.
The results from this will be used to develop a 30 question, disease-specific questionnaire.
The final step will be to readminister this survey, in conjunction with the SF-36 or CHQ PF, and follow up, in two weeks, with a second administration of the aforementioned surveys, in order to test the variability and validity of the disease-specific, health-related, quality of life score.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients or parents of child patients in British Columbia.
Description
Inclusion Criteria:
- Must be diagnosed with Hereditary Multiple Exostoses
- Adult patients or parents of child patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF-36 score for adults and CHQ PF-50 for children
Time Frame: No time frame
|
No time frame
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 16, 2007
First Posted (ESTIMATE)
May 17, 2007
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Bone Diseases
- Neoplastic Syndromes, Hereditary
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Bone Diseases, Developmental
- Osteochondrodysplasias
- Hyperostosis
- Osteochondroma
- Exostoses, Multiple Hereditary
- Osteochondromatosis
- Exostoses
- Osteophyte
Other Study ID Numbers
- H07-00457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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