ClinicalTrials.gg
CompletedNCT00474344Updated May 18, 2022

Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)

An observational study in Clubfoot, sponsored by University of British Columbia. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by University of British Columbia · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
370
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Clubfoot with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Clubfoot · United States.

Started
2004
the only one that year
Observational
5 of 10
1 open now
Registered
1st of 10
by date
Lead sponsor
1 of 10
University of British Columbia

Among the 10 studies in Clubfoot with a site in United States, this one is the only one that started in 2004, is one of 5 observational ones, and was the 1st registered.

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

Browse Clubfoot studies →

Open to participants now

2 of the 10 studies in Clubfoot with a site in United States are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

The goal of this study is to identify and characterize the genetic loci causing idiopathic talipes equinovarus (clubfoot).

The hypothesis is that a few genes account for a substantial fraction of ITEV and that these genes can be identified in defined populations. Towards this goal, in preliminary studies, Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for linkage and association to ITEV.

Read the detailed description

Blood Collection: For this study, the investigators need to obtain blood samples from members of families in which clubfoot has occurred; more specifically, blood samples from the affected child and both parents. DNA will be extracted from blood samples. The DNA will then be tested to look for genetic factors that cause clubfoot.

Study Questionnaires: As well as the blood samples, the investigators have a short questionnaire for the mother of the child with clubfoot to complete.

03

Conditions studied

  • Clubfoot

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Keywords

  • Genetics
  • Clubfoot
  • DNA
  • Idiopathic Talipes Equinovarus also known as Clubfoot
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

One family member, usually child, must have clubfoot.

Eligibility criteria

Inclusion Criteria:

  • One family member, usually child, must have clubfoot
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
370 participants (actual)
06

Study locations

2 sites
  • University of Texas
    Houston, Texas, United States
  • BC Children's Hospital
    Vancouver, British Columbia V6H 3V4, Canada
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2004, a primary completion of Dec 2010 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2007
First posted
May 16, 2007
Start
Aug 2004
Primary completionActual
Dec 2010
CompletionActual
Aug 2013
Last update
May 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00474344
Collaborators
National Institutes of Health (NIH), Shriners Hospitals for Children
Responsible party
Christine Alvarez (Principle Investigator, University of British Columbia) — Principal investigator
First posted
May 16, 2007
Start date
Aug 2004
Primary completion
Dec 2010
Completion
Aug 2013
Last update
May 18, 2022

Study contacts

Christine Alvarez, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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