PregnancyNCT01451684
Development of a Non-invasive Prenatal Test
An observational study of Pregnancy, run by Cindy Cisneros at 1 site in United States.
Trial summary
This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2019
- 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: This study will include women who have a healthy pregnancy.
Who may be able to join
- Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
- Subject is able to provide informed consent
- Subject is ≥ 18 years of age
- Subject is at least 10 weeks gestation for general enrollment
- Subject has no known risk factors for chromosomal abnormalities of the fetus
- Subject has no suspected or confirmed fetal abnormalities
Who cannot join
- Subject is pregnant with more than two fetuses
- Subject is unwilling to undergo a blood draw
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.
Read the detailed description
Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.
- Conditions
- Pregnancy
- Keywords
- pregnancy, fetus, euploid
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of chromosomal abnormality
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2019
- Study completionDec 2019
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cindy Cisneros
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Cindy Cisneros, Roche Sequencing Solutions
- Investigators
- Tracy Roberts, Study director, Ariosa Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451684
- Sponsor's protocol ID
- TD003
- Status last verified
- Apr 2020
- First submitted
- 10 Oct 2011
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Non-invasive Prenatal Test
- ClinicalTrials.gov ID
- NCT01451684
- Acronym / sponsor ID
- TD003
- Conditions
- Pregnancy
- Keywords
- pregnancy, fetus, euploid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Cindy CisnerosIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Oct 2011 (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.
This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.
Detailed description
Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.
Study design
- Observational model
- Case only
- 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
- This study will include women who have a healthy pregnancy.
Key inclusion criteria (6 listed)
- Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
- Subject is able to provide informed consent
- Subject is ≥ 18 years of age
- Subject is at least 10 weeks gestation for general enrollment
- Subject has no known risk factors for chromosomal abnormalities of the fetus
Key exclusion criteria (2 listed)
- Subject is pregnant with more than two fetuses
- Subject is unwilling to undergo a blood draw
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
Absence of chromosomal abnormality
Time frame: At time of enrollment
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 30 Apr 2020.
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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.
Tracy Roberts study director
Ariosa Diagnostics
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 Pregnancy, run by Cindy Cisneros 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 6 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: finished, as of the sponsor's last update on 30 Apr 2020. 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?
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?
Absence of chromosomal abnormality (time frame: At time of enrollment). 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 30 Apr 2020.