Clubfoot DNA Repository

NCT00607191 | Completed DMC

• 1 other identifier: UTSW 122007-004
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 1

Brief Summary

To build a DNA repository to enable participation in ongoing and future Clubfoot genetic linkage studies.

Conditions

Clubfoot

Keywords

Idiopathic talipes equinovarus (ITEV)

Outcome Measures

Primary Outcomes (1)

• To identify a gene, or genes, that are associated with isolated clubfoot.

  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.

  10 years

Eligibility Criteria

• Age: 1 Week - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated at the participating facilities with a diagnosis of clubfoot, and their affected family members.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

Related Links

• Texas Scottish Rite Hospital for Children

Biospecimen

Retention: SAMPLES WITH DNA

Each of the study participants (affected and non-affected individuals) will be asked to provide DNA from a blood sample. A 10cc sample of blood will be removed on 1 or 2 occasions by drawing blood from the arm or by finger stick by research staff. If the participant is a child who will be undergoing surgery, the blood sample will be collected at that time to eliminate additional stick. If collecting a blood sample is not possible we can also obtain DNA by collecting a saliva sample. This second technique does not give us as much DNA as we would get from blood. Therefore, if we get saliva samples, we might require more than one saliva sample over the course of the study.

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jonathan Rios, PhD

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2008
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)