AneuploidyNCT01256606
Prenatal Test for Fetal Aneuploidy Detection
An observational study of Aneuploidy and Trisomy 21, run by Roche Sequencing Solutions at 6 sites in United States.
Trial summary
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy, Trisomy 21
- How many people
- 4,000 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2010to Nov 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation
Who may be able to join
- Subject is 18yrs or older
- Subject has a singleton pregnancy
- Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
- Subject is able to provide consent
Who cannot join
- Subject is pregnant with more than one fetus
- Subject (mother) has known aneuploidy
- Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
- Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Atlanta Perinatal Consultants
Atlanta, Georgia, 30342
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
East Bay Perinatal Medical Associates
Oakland, California, 94609
Prenatal Diagnosis of Northern California
Sacramento, California, 95815
University of California - San Diego
San Diego, California, 92121
University of California - San Francisco
San Francisco, California, 94122
About this study
Official title: Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
- Conditions
- Aneuploidy, Trisomy 21
- Medical subject headings
- Aneuploidy, Down 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 |
|---|---|---|
| Positive for fetal aneuploidy | Not described | |
| Negative for fetal aneuploidy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneuploidyStudies 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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roche Sequencing Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Song, MD, Study director, Ariosa Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256606
- Sponsor's protocol ID
- TT001
- Status last verified
- Jan 2013
- First submitted
- 22 Nov 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy
- ClinicalTrials.gov ID
- NCT01256606
- Acronym / sponsor ID
- TT001
- Conditions
- Aneuploidy, Trisomy 21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Roche Sequencing SolutionsIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Dec 2010 (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 develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for fetal aneuploidy | – | – |
| Negative for fetal aneuploidy | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation
Key inclusion criteria (4 listed)
- Subject is 18yrs or older
- Subject has a singleton pregnancy
- Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
- Subject is able to provide consent
Key exclusion criteria (4 listed)
- Subject is pregnant with more than one fetus
- Subject (mother) has known aneuploidy
- Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
- Subject has already undergone CVS or amniocentesis during current pregnancy prior to study 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
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
Time frame: 24 months
Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.
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 10 Jan 2013.
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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.
Ken Song, MD study director
Ariosa Diagnostics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneuploidy and Trisomy 21, run by Roche Sequencing Solutions at 6 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 4 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection (time frame: 24 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 10 Jan 2013.