PregnancyNCT00971334
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
An observational study of Pregnancy and Aneuploidy, run by Sequenom, Inc. at 35 sites in 2 countries.
Trial summary
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Aneuploidy, Down Syndrome
- How many people
- 2,502 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Aug 2009to Dec 2011
- 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: Pregnant women who are scheduled to undergo a CVS or amniocentesis procedure and will receive the FISH, karyotype and/or QF-PCR results from the procedure.
Who may be able to join
- Subject is female
- Subject is pregnant
- Subject is 18 years of age or older
- Subject provides a signed and dated informed consent
- Subject agrees to provide a 30-50mL blood sample
- Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
- Subject plans to undergo an amniocentesis and/or CVS procedure
- Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided
Who cannot join
- None
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States30 sites
Women's Clinic
Boise, Idaho, 83712
Visions Clinical Research
Boynton Beach, Florida, 33472
Cooper University Hospital
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Reproductive Genetics Institute
Chicago, Illinois, 60602
Complete Healthcare for Women
Columbus, Ohio, 43231
Clinical Trials of America
Eugene, Oregon, 97401
Spectrum Health - Maternal Fetal Medicine
Grand Rapids, Michigan, 49503
Fetal Diagnostic Institution of the Pacific
Honolulu, Hawaii, 96814
Houston Perinatal Associates
Houston, Texas, 77054
Kingsport Perinatology
Kingsport, Tennessee, 37660
Grossmont Center for Clinical Research
La Mesa, California, 91942
University of Miami
Miami, Florida, 33136
South Florida Perinatal Medicine
Miami, Florida, 33143
University of South Alabama
Mobile, Alabama, 36604-3302
Perinatal Research Center
Nashville, Tennessee, 37203
Tenessee Maternal Fetal Medicine
Nashville, Tennessee, 37203
Methodist Hospital
Omaha, Nebraska, 68022
Global Ob/Gyn Centers
Pembroke Pines, Florida, 33323
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
IGO
San Diego, California, 92121
San Diego Perinatal Center
San Diego, California, 92123
Women's Healthcare at Frost Street
San Diego, California, 92123
Poway Womens Care
San Diego, California, 92128
St Louis University
St Louis, Missouri, 63117
Discovery Clinical Research
Sunrise, Florida, 33323
Sheridan Clinical Research
Sunrise, Florida, 33323
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
France5 sites
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Hopital Cochin Port Royal
Paris, 75019
Hopital Robert Debre
Paris, 75019
Hopital Paule de Viguier - CHU Toulouse
Toulouse, 31026
Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
Tours, 37044
About this study
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
- Conditions
- Pregnancy, Aneuploidy, Down Syndrome, Edwards Syndrome
- Keywords
- Down Syndrome, Aneuploidy, Amniocentesis, CVS
- Medical subject headings
- Aneuploidy, Down Syndrome, Trisomy 18 Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Time perspective
- Prospective
- Enrolment
- 2,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Allan T Bombard, MD, Study director, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971334
- Sponsor's protocol ID
- SQNM-T21-202
- Status last verified
- Feb 2012
- First submitted
- 1 Sep 2009
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
- ClinicalTrials.gov ID
- NCT00971334
- Acronym / sponsor ID
- SQNM-T21-202
- Conditions
- Pregnancy, Aneuploidy, Down Syndrome, Edwards Syndrome
- Keywords
- Down Syndrome, Aneuploidy, Amniocentesis, CVS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,502 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Sep 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 purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who are scheduled to undergo a CVS or amniocentesis procedure and will receive the FISH, karyotype and/or QF-PCR results from the procedure.
Key inclusion criteria (8 listed)
- Subject is female
- Subject is pregnant
- Subject is 18 years of age or older
- Subject provides a signed and dated informed consent
- Subject agrees to provide a 30-50mL blood sample
Key exclusion criteria (1 listed)
- None
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
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 17 Feb 2012.
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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 T Bombard, MD study director
Sequenom, Inc.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Aneuploidy, run by Sequenom, Inc. at 35 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, 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 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.
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 17 Feb 2012.