Turner SyndromeNCT01668251
Turner Syndrome Prenatal Diagnosis Study
An observational study of Turner Syndrome, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason. Read more about this study
- Who is it for?
- Ages Up to 3 months, women only
- Conditions the study is for
- Turner Syndrome
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 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 Up to 3 months
- Women only
- No healthy volunteers
- Child
Study population: Girls who are diagnosed with Turner syndrome prenatally.
Who may be able to join
- Turner syndrome diagnosed prenatally
- Less than 4 months of age at time of enrollment
Who cannot join
- Turner syndrome diagnosed postnatally
- Older than 4 months of age at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Patricia Fechner, M.D., 800-317-7589, patricia.fechner@seattlechildrens.org
Sue Kearns, RN, 1-206-987-1758, sue.kearns@seattlechildrens.org
About this study
Official title: National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes
The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.
Read the detailed description
This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age.
No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.
- Conditions
- Turner Syndrome
- Keywords
- Turner syndrome, Diagnosis, prenatal
- Medical subject headings
- Turner Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fetal ascertainment | Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound. | |
| Maternal ascertainment | Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of signs of Turner syndrome
Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment
Measured: three to six years
Secondary outcomes (1)
Growth
Do girls with Turner syndrome ascertained by fetal ascertainment grow differently than girls ascertained by maternal ascertainment.
Measured: three to six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJan 2006
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Patricia Fechner, Seattle Children's Hospital
- Investigators
- Patricia Fechner, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668251
- Sponsor's protocol ID
- TS Prenatal Study
- Status last verified
- Aug 2012
- First submitted
- 3 Nov 2011
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. doi: 10.1542/peds.2003-1122-L.
PubMed 15342833
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Collaborative Study of Girls Prenatally Diagnosed With Turner Syndrome Karyotypes
- ClinicalTrials.gov ID
- NCT01668251
- Acronym / sponsor ID
- TS Prenatal Study
- Conditions
- Turner Syndrome
- Keywords
- Turner syndrome, Diagnosis, prenatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2006
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Aug 2012 (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.
The goal of this study is to compare the features of Turner syndrome in girls who are diagnosed before birth because of fetal concerns versus those who are diagnosed when their mother has an amniocentesis for another reason.
Detailed description
This is an observational study which will look at girls who are diagnosed with Turner syndrome before they are born. Girls will be divided into two groups: 1) those diagnosed because of features seen on ultrasound which raised the question of Turner syndrome and 2) those diagnosed incidentally when their mother had an amniocentesis for another reason such as advanced maternal age.
No clinical procedures nor interventions will be done as part of this data collection study which will occur for the first 3 to 6 years of the girl's life. The investigators will be looking to see if girls who are diagnosed incidentally have less features of Turner syndrome than those girls who are diagnosed because of fetal ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal ascertainment | – | –Girls who are diagnosed with Turner syndrome because of concerns raised by an abnormal fetal ultrasound. |
| Maternal ascertainment | – | –Girls who are diagnosed with Turner syndrome because their mothers had an amniocentesis for a reason other than an abnormal fetal ultrasound concerning for Turner syndrome. For example an amniocentesis was done because of advanced maternal age or because of an abnormal triple screen or because another condition was being screened for such as trisomy 21. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Girls who are diagnosed with Turner syndrome prenatally.
Key inclusion criteria (2 listed)
- Turner syndrome diagnosed prenatally
- Less than 4 months of age at time of enrollment
Key exclusion criteria (2 listed)
- Turner syndrome diagnosed postnatally
- Older than 4 months of age at time of enrollment
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
Number of signs of Turner syndrome
Time frame: three to six years
Girls diagnosed with Turner syndrome by fetal ascertainment will have more signs of Turner syndrome than girls diagnosed by maternal ascertainment
1 secondary outcome
Growth
Time frame: three to six years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Background: PubMed 15342833Gunther DF, Eugster E, Zagar AJ, Bryant CG, Davenport ML, Quigley CA. Ascertainment bias in Turner syndrome: new insights from girls who were diagnosed incidentally in prenatal life. Pediatrics. 2004 Sep;114(3):640-4. doi: 10.1542/peds.2003-1122-L.
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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.
Patricia Fechner, MD principal investigator
Seattle Children's Hospital
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 Turner Syndrome, run by Seattle Children's Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 20 Aug 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Fechner, MD (206-987-5037, patricia.fechner@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of signs of Turner syndrome (time frame: three to six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668251, which also lists 1 linked publication.
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 20 Aug 2012.