Cleft LipNCT00213889
TWIST Human Gene and Cleft Lips and Palates
A study testing None: molecular genetics diagnosis procedure only in people with Cleft Lip, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Cleft Lip
- What is being tested?
- None: molecular genetics diagnosis procedure only
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2003to Jul 2008
- Phase
- Interventional
- 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 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged from 1 month to 18 years:
- Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so
- Healthcare insurance holders
- Display facial clefting
- Grown patients over 18 years of age:
- Agree to enrollment
- Display facial clefting
- Healthcare insurance holders
Who cannot join
- Patients declining enrollment
- Patients without healthcare insurance
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
About this study
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.
- Conditions
- Cleft Lip
- Being tested
- None: molecular genetics diagnosis procedure only
- Keywords
- Facial clefting, twist, craniofacial development genes, Human cleft lip and palate, cleft lip and palate
- Medical subject headings
- Cleft Lip, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None: molecular genetics diagnosis procedure onlyOther
None: molecular genetics diagnosis procedure only
What is being measured
The primary outcome is the main question the study is designed to answer.
to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development
Measured: Not relevant
Secondary outcomes (1)
to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes
Measured: Not relevant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal TSCHILL, MD, Principal investigator, Laboratoire de Génétique Molécules des Eucaryotes (LGME)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213889
- Sponsor's protocol ID
- 2602
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 27 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TWIST Human Gene and Cleft Lips and Palates
- ClinicalTrials.gov ID
- NCT00213889
- Acronym / sponsor ID
- 2602
- Conditions
- Cleft Lip
- Keywords
- Facial clefting, twist, craniofacial development genes, Human cleft lip and palate, cleft lip and palate
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 Sep 2005 (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.
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so
- Healthcare insurance holders
- Display facial clefting
- Agree to enrollment
- Display facial clefting
Key exclusion criteria (2 listed)
- Patients declining enrollment
- Patients without healthcare insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None: molecular genetics diagnosis procedure onlyNone: molecular genetics diagnosis procedure only | Other | – |
Primary outcome
to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development
Time frame: Not relevant
1 secondary outcome
to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes
Time frame: Not relevant
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Pascal TSCHILL, MD principal investigator
Laboratoire de Génétique Molécules des Eucaryotes (LGME)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing None: molecular genetics diagnosis procedure only in people with Cleft Lip, run by University Hospital, Strasbourg, France at 4 sites in France.
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 8 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: stopped early, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. 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.
What does the primary outcome measure?
to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development (time frame: Not relevant). 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 27 Mar 2015.