Fetal ComplicationsNCT01451671
Development of a Prenatal Test for Fetal Aneuploidy Detection
An observational study of Fetal Complications, run by Cindy Cisneros at 3 sites in United States.
Trial summary
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Complications
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Nov 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: Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.
Who may be able to join
- Subject has singleton pregnancy
- Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
- Subject is able to provide informed consent
- Subject is ≥ 18 years of age
Who cannot join
- Subject is pregnant with more than one fetus
- Subject (mother) has a known aneuploidy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Norton Healthcare
Louisville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of California San Diego
San Diego, California, 92037
About this study
Official title: Prenatal Test for Fetal Aneuploidy Detection
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.
- Conditions
- Fetal Complications
- Keywords
- fetal, aneuploidy, non-invasive, prenatal, cell free DNA
- Medical subject headings
- Aneuploidy
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of aneuploidy
Measured: At 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 startNov 2010
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal ComplicationsStudies 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
- 1,500 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
- NCT01451671
- Sponsor's protocol ID
- TD002
- 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
- Prenatal Test for Fetal Aneuploidy Detection
- ClinicalTrials.gov ID
- NCT01451671
- Acronym / sponsor ID
- TD002
- Conditions
- Fetal Complications
- Keywords
- fetal, aneuploidy, non-invasive, prenatal, cell free DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Cindy CisnerosIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 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 develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.
Study design
- Observational model
- Case-control
- 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 carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.
Key inclusion criteria (4 listed)
- Subject has singleton pregnancy
- Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
- Subject is able to provide informed consent
- Subject is ≥ 18 years of age
Key exclusion criteria (2 listed)
- Subject is pregnant with more than one fetus
- Subject (mother) has a known aneuploidy
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
Identification of aneuploidy
Time frame: At 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Complications, run by Cindy Cisneros at 3 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 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 3 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?
Identification of aneuploidy (time frame: At 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.