Down Syndrome (Trisomy 21)NCT00770458
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
An observational study of Down Syndrome (Trisomy 21) and Edwards Syndrome (Trisomy 18), run by Sequenom, Inc. at 7 sites in United States.
Trial summary
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13)
- How many people
- 1,000 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2008to 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
- No healthy volunteers
- Adult, Older adult
Study population: Fetal care and genetic counseling patients.
Who may be able to join
- Subject is female
- Subject is pregnant
- Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
- Subject is willing to provide blood specimen
Who cannot join
- Subject is not pregnant
- Subject is not willing to provide blood specimen
- Subject is not haveing aneuploid screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Obstetrix Medical Group of Colorado
Denver, Colorado, 80218
UCSD Fetal Care & Genetics Center
La Jolla, California, 92037
Women & Infants
Providence, Rhode Island, 02903
A.R.U.P.
Salt Lake City, Utah, 84108
San Diego Perinatal Center
San Diego, California, 92123
Obstetrix Medical Group of San Jose
San Jose, California, 95008
Obstetrix Medical Group of Washington
Seattle, Washington, 98104
About this study
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
- Conditions
- Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome
- Keywords
- Down Syndrome
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Turner Syndrome
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 |
|---|---|---|
| Pregnant women | Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare investigational assay results for Down Syndrome to standard of care results.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionDec 2009
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Allan Bombard, MD, Study director, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770458
- Sponsor's protocol ID
- SQNM-Trisomy21-0100
- Status last verified
- Jan 2010
- First submitted
- 8 Oct 2008
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
- ClinicalTrials.gov ID
- NCT00770458
- Acronym / sponsor ID
- SQNM-Trisomy21-0100
- Conditions
- Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome
- Keywords
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Oct 2008 (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.
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fetal care and genetic counseling patients.
Key inclusion criteria (4 listed)
- Subject is female
- Subject is pregnant
- Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
- Subject is willing to provide blood specimen
Key exclusion criteria (3 listed)
- Subject is not pregnant
- Subject is not willing to provide blood specimen
- Subject is not haveing aneuploid screening
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
Compare investigational assay results for Down Syndrome to standard of care results.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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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.
Allan Bombard, MD study director
Sequenom, 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 Edwards Syndrome (Trisomy 18), run by Sequenom, Inc. 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jan 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare investigational assay results for Down Syndrome to standard of care results. (time frame: 3 months). 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 6 Jan 2010.