Down Syndrome (Trisomy 21)NCT00891852
Non-Invasive Determination of Fetal Chromosome Abnormalities
An observational study of Down Syndrome (Trisomy 21) and Edward's Syndrome (Trisomy 18), run by Lenetix Medical Screening Laboratory at 7 sites in United States.
Trial summary
The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13)
- How many people
- 1,000 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2009to Dec 2009
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators anticipate enrolling 1000 subjects who are presenting for prenatal diagnosis by CVS or genetic amniocentesis for increased risk for fetal aneuploidy.
Who may be able to join
- This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.
Who cannot join
- The only exclusion criteria are those mentioned.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
UVM
Burlington, Vermont, 05405
Stephen A Brown, MD, 802-656-4775, stephen.brown@uvm.edu
- Recruiting
Winthrop University Hospital
Mineola, New York, 11501
Martin Chavez, MD, 516-663-3020, mchavez@winthrop.org
- Recruiting
Atlantic Maternal Fetal Medicine
Moristown, New Jersey, 07960
Diane London, Perinatal Nurse, 973-971-7080, diane.london@atlantichealth.com
- Recruiting
Elite Women's Health
New Hyde Park, New York, 11042
Jonathan D Herman, MD, 516-358-1200, jdherman@gmail.com
- Recruiting
Columbia University, NewYork-Presbyterian Hospital
New York, New York, 10022
Erica Speigel, GC, 212-305-1327, ess2113@columbia.edu
Anne Van Der Veer, 212-305-1327, av2284@columbia.edu
- Recruiting
New York Perinatal Associates
New York, New York, 10128
Daniel Saltzman, MD, 201-370-5277, dsaltzman@mfmnyc.com
- Recruiting
Maryland Perinatal Associates
Rockville, Maryland, 20850
Elizabeth Kramer, GC, 301-251-8611, ekramer@lenetix.com
About this study
The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.
- Conditions
- Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Klinefelter Syndrome (47, XXY), and Other Chromosome, Abnormalities.
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Klinefelter Syndrome, Congenital Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (Trisomy 21)Studies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenetix Medical Screening Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen A Brown, MD, Principal investigator, Lenetix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891852
- Sponsor's protocol ID
- 110106-1
- Status last verified
- Apr 2009
- First submitted
- 29 Apr 2009
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Determination of Fetal Chromosome Abnormalities
- ClinicalTrials.gov ID
- NCT00891852
- Acronym / sponsor ID
- 110106-1
- Conditions
- Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Klinefelter Syndrome (47, XXY), and Other Chromosome, Abnormalities.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lenetix Medical Screening LaboratoryIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 1 May 2009 (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 overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators anticipate enrolling 1000 subjects who are presenting for prenatal diagnosis by CVS or genetic amniocentesis for increased risk for fetal aneuploidy.
Key inclusion criteria (1 listed)
- This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.
Key exclusion criteria (1 listed)
- The only exclusion criteria are those mentioned.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2009.
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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.
Stephen A Brown, MD principal investigator
Lenetix, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome (Trisomy 21) and Edward's Syndrome (Trisomy 18), run by Lenetix Medical Screening Laboratory at 7 sites 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 1 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 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 1 May 2009.