ClubfootNCT00607191
Clubfoot DNA Repository
An observational study of Clubfoot, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies. Read more about this study
- Who is it for?
- Ages 1 week to 75 years
- Conditions the study is for
- Clubfoot
- How many people
- 379 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to 4 May 2017
- 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 week to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients being treated at the participating facilities with a diagnosis of clubfoot, and their affected family members.
Who may be able to join
- For a family to be included in this study there should be at least one person in the family affected with Idiopathic Talipes Equinovarus (or clubfoot). If the person satisfies this criterion, then the affected person and his/her parents are included in the study. If there are other individuals in the family who are also affected (e.g. a cousin), then these individuals are also invited to participate in the study along with their parents, siblings and all other family members that link the two affected individuals (e.g. grandparents).
Who cannot join
- Inability to speak and read English or Spanish
- Should not have any other major birth defect (e.g. Heart defects, Downs Syndrome or cerebral palsy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
About this study
To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies.
Read the detailed description
Clubfoot is a birth defect that can occur alone (in isolation) or as a part of a disease like cerebral palsy (CP). Genetic linkage is a research tool in which DNA samples are tested for genetic landmarks (markers) whose location on chromosomes is known. Genes and markers that are physically close to one another on the chromosome are said to be tightly linked than genes and markers that are located far apart. This gives clues of where to search for genes causing isolated clubfoot. If there appears to be a high correlation between family members' inheritance of a particular marker, and their inheritance of the trait being studied (in this case clubfoot), the area of the chromosome near that marker can then be searched for a likely gene which causes the trait. It is hoped that genetic linkage research might eventually result in new or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Our research staff will obtain information about each subject and their family called a pedigree. We will then administer a one page questionnaire to the mother(s) of the affected individual(s). This questionnaire will ask about the mother's experiences during pregnancy (e.g. Did she take multivitamins? Did she smoke or drink? etc.)
Each of the study participants (affected and non-affected individuals) will be asked to provide DNA from a blood sample. If collecting a blood sample is not possible we can also obtain DNA by collecting a saliva sample.
Samples for DNA processing will be stored according to the following repository guidelines. Patient/donor-subject information, questionnaires, and consents will be maintained by the orthopaedic research coordinator.
Samples will be made to investigators not affiliated with UT Southwestern who wish to study genetic factors that cause clubfoot; for example, we have recently been approached by Jacqueline Hecht (UT Health Science Center, Houston) and Matthew Dobbs (Washington University, St. Louis) regarding participation in their multicenter trials. Samples will be de-identified and will include no personal information which would link the sample to the donor subject.
Primary investigator and sub-investigators will determine how samples will be used and by whom. Additional research utilizing subjects' samples will be approved by the Texas Scottish Rite Hospital for Children Research Advisory Panel and the Institutional Review Board at UT Southwestern.
- Conditions
- Clubfoot
- Keywords
- Idiopathic talipes equinovarus (ITEV)
- Medical subject headings
- Clubfoot
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify a gene, or genes, that are associated with isolated clubfoot.
Measured: 10 years
Secondary outcomes (1)
New or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completion4 May 2017
- Study completion4 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Rios, PhD, Texas Scottish Rite Hospital for Children
- Investigators
- Jonathan Rios, PhD, Principal investigator, Texas Scottish Rite Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607191
- Sponsor's protocol ID
- UTSW 122007-004
- Status last verified
- May 2017
- First submitted
- 22 Jan 2008
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clubfoot DNA Repository
- ClinicalTrials.gov ID
- NCT00607191
- Acronym / sponsor ID
- UTSW 122007-004
- Conditions
- Clubfoot
- Keywords
- Idiopathic talipes equinovarus (ITEV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 5 Feb 2008 (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.
To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies.
Detailed description
Clubfoot is a birth defect that can occur alone (in isolation) or as a part of a disease like cerebral palsy (CP). Genetic linkage is a research tool in which DNA samples are tested for genetic landmarks (markers) whose location on chromosomes is known. Genes and markers that are physically close to one another on the chromosome are said to be tightly linked than genes and markers that are located far apart. This gives clues of where to search for genes causing isolated clubfoot. If there appears to be a high correlation between family members' inheritance of a particular marker, and their inheritance of the trait being studied (in this case clubfoot), the area of the chromosome near that marker can then be searched for a likely gene which causes the trait. It is hoped that genetic linkage research might eventually result in new or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Our research staff will obtain information about each subject and their family called a pedigree. We will then administer a one page questionnaire to the mother(s) of the affected individual(s). This questionnaire will ask about the mother's experiences during pregnancy (e.g. Did she take multivitamins? Did she smoke or drink? etc.)
Each of the study participants (affected and non-affected individuals) will be asked to provide DNA from a blood sample. If collecting a blood sample is not possible we can also obtain DNA by collecting a saliva sample.
Samples for DNA processing will be stored according to the following repository guidelines. Patient/donor-subject information, questionnaires, and consents will be maintained by the orthopaedic research coordinator.
Samples will be made to investigators not affiliated with UT Southwestern who wish to study genetic factors that cause clubfoot; for example, we have recently been approached by Jacqueline Hecht (UT Health Science Center, Houston) and Matthew Dobbs (Washington University, St. Louis) regarding participation in their multicenter trials. Samples will be de-identified and will include no personal information which would link the sample to the donor subject.
Primary investigator and sub-investigators will determine how samples will be used and by whom. Additional research utilizing subjects' samples will be approved by the Texas Scottish Rite Hospital for Children Research Advisory Panel and the Institutional Review Board at UT Southwestern.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients being treated at the participating facilities with a diagnosis of clubfoot, and their affected family members.
Key inclusion criteria (1 listed)
- For a family to be included in this study there should be at least one person in the family affected with Idiopathic Talipes Equinovarus (or clubfoot). If the person satisfies this criterion, then the affected person and his/her parents are included in the study. If there are other individuals in the family who are also affected (e.g. a cousin), then these individuals are also invited to participate in the study along with their parents, siblings and all other family members that link the two affected individuals (e.g. grandparents).
Key exclusion criteria (2 listed)
- Inability to speak and read English or Spanish
- Should not have any other major birth defect (e.g. Heart defects, Downs Syndrome or cerebral palsy).
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
To identify a gene, or genes, that are associated with isolated clubfoot.
Time frame: 10 years
1 secondary outcome
New or improved ways to determine individuals and families at higher risk for clubfoot and development of new or improved ways to treat clubfoot.
Time frame: 10 years
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 9 May 2017.
- Texas Scottish Rite Hospital for ChildrenLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Rios, PhD principal investigator
Texas Scottish Rite Hospital for Children
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 Clubfoot, run by Texas Scottish Rite Hospital for Children 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 2 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 9 May 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?
To identify a gene, or genes, that are associated with isolated clubfoot. (time frame: 10 years). 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 9 May 2017.