AneuploidyNICHENCT02201862
Non-Invasive Chromosomal Evaluation of Trisomy Study
An observational study of Aneuploidy and Trisomy 21, run by Cindy Cisneros at 3 sites in United States.
Trial summary
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control. 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, Trisomy 18
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to 1 Aug 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women planning to undergo chorionic villus sampling (CVS) and/or amniocentesis for the purpose of genetic evaluation of the fetus.
Who may be able to join
- 1. Subject is at least 18 years old and can provide informed consent;
- 2. Subject has a viable singleton or twin pregnancy;
- 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
- 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
Who cannot join
- 1. Subject has known aneuploidy;
- 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
- 3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
- 4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Regional Obestrical Consultants
Chattanooga, Tennessee, 37403
Women's Healthcare Group of PA
Oaks, Pennsylvania, 19456
University California San Diego
San Diego, California
About this study
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
- Conditions
- Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13, Down Syndrome
- Keywords
- Aneuploidy, Down Syndrome, amniocentesis, chronic villus sampling, Trisomy, non-invasive prenatal testing, Chromosome disorders
- Medical subject headings
- Aneuploidy, Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Trisomy, Chromosome Disorders
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 |
|---|---|---|
| Euploid Subjects | Subject's with fetal euploidy confirmed by chromosome analysis | |
| Aneuploid Subjects | Subject's with fetal aneuploidy confirmed by chromosome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of aneuploidy
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 posted28 Jul 2014 (estimated)
- Study startApr 2014
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cindy Cisneros
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Cindy Cisneros, Roche Sequencing Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201862
- Sponsor's protocol ID
- AD201
- Acronym
- NICHE
- Status last verified
- Apr 2020
- First submitted
- 22 Jul 2014
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.
PubMed 22742782
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
- Non-Invasive Chromosomal Evaluation of Trisomy Study
- ClinicalTrials.gov ID
- NCT02201862
- Acronym / sponsor ID
- NICHE / AD201
- Conditions
- Aneuploidy, Trisomy 21, Trisomy 18, Trisomy 13, Down Syndrome
- Keywords
- Aneuploidy, Down Syndrome, amniocentesis, chronic villus sampling, Trisomy, non-invasive prenatal testing, Chromosome disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Cindy CisnerosIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Jul 2014 (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 study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euploid Subjects | – | –Subject's with fetal euploidy confirmed by chromosome analysis |
| Aneuploid Subjects | – | –Subject's with fetal aneuploidy confirmed by chromosome analysis |
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 (CVS) and/or amniocentesis for the purpose of genetic evaluation of the fetus.
Key inclusion criteria (4 listed)
- 1. Subject is at least 18 years old and can provide informed consent;
- 2. Subject has a viable singleton or twin pregnancy;
- 3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
- 4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
Key exclusion criteria (4 listed)
- 1. Subject has known aneuploidy;
- 2. Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
- 3. Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
- 4. Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant;
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
Detection of aneuploidy
Time frame: 24 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 30 Apr 2020.
- Background: PubMed 22742782Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneuploidy and Trisomy 21, 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 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 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?
Detection of aneuploidy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201862, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 31 Oct 2026.