Pregnant WomenMELISSANCT01122524
MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy
An observational study of Pregnant Women and Prenatal Care, run by Verinata Health, Inc. at 11 sites in United States.
Trial summary
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women, Prenatal Care
- How many people
- 10,000 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2010to Oct 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 undergoing chorionic villus sampling (CVS) or amniocentesis
Who may be able to join
- Age 18 years or older
- Clinically confirmed viable pregnancy at the time of enrollment
- Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
- Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
- Able to provide consent for participation using language appropriate forms and consent process
Who cannot join
- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New Mexico Consortium for Perinatal Research
Albuquerque, New Mexico, 87109
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Visions Clinical Research
Boynton Beach, Florida, 33437
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Women's Clinic of Northern Colorado
Fort Collins, Colorado, 80524
The Women's Hospital of Texas
Houston, Texas, 77054
Center for Fetal Medicine
Los Angeles, California, 90048
Winthrop University Hospital
Mineola, New York, 11501
Eastern Virginia Medical School
Norfolk, Virginia, 23507
San Francisco Perinatal Associates
San Francisco, California, 94109
OB/Gyn Specialists of the Palm Beaches
West Palm Beach, Florida, 33401
About this study
Official title: A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).
Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
- Conditions
- Pregnant Women, Prenatal Care
- Keywords
- Trisomy 21
- Medical subject headings
- 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 |
|---|---|---|
| Chromosomal Abnormality | Fetus affected by chromosomal abnormality | |
| No Chromosomal Abnormality | Fetus not affected by chromosomal abnormality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verinata Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy J Sehnert, MD, Study director, Verinata Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122524
- Sponsor's protocol ID
- ART-0006
- Acronym
- MELISSA
- Status last verified
- Oct 2011
- First submitted
- 11 May 2010
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
Bianchi DW, Prosen T, Platt LD, Goldberg JD, Abuhamad AZ, Rava RP, Sehnert AJ; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group*. Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma. Obstet Gynecol. 2013 May;121(5):1057-1062. doi: 10.1097/AOG.0b013e31828ba3d8.
PubMed 23635743Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482.
PubMed 22362253
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
- ClinicalTrials.gov ID
- NCT01122524
- Acronym / sponsor ID
- MELISSA / ART-0006
- Conditions
- Pregnant Women, Prenatal Care
- Keywords
- Trisomy 21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Verinata Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 May 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 primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).
Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromosomal Abnormality | – | –Fetus affected by chromosomal abnormality |
| No Chromosomal Abnormality | – | –Fetus not affected by chromosomal abnormality |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women undergoing chorionic villus sampling (CVS) or amniocentesis
Key inclusion criteria (5 listed)
- Age 18 years or older
- Clinically confirmed viable pregnancy at the time of enrollment
- Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
- Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
- Able to provide consent for participation using language appropriate forms and consent process
Key exclusion criteria (1 listed)
- Invasive prenatal procedure (amniocentesis or CVS) performed prior to 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
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Time frame: 10 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 10 Oct 2011.
- Backgroundhttp://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
- Derived from this study: PubMed 23635743Bianchi DW, Prosen T, Platt LD, Goldberg JD, Abuhamad AZ, Rava RP, Sehnert AJ; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group*. Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma. Obstet Gynecol. 2013 May;121(5):1057-1062. doi: 10.1097/AOG.0b013e31828ba3d8.
- Derived from this study: PubMed 22362253Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482.
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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.
Amy J Sehnert, MD study director
Verinata Health, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Prenatal Care, run by Verinata Health, Inc. at 11 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 5 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 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. (time frame: 10 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 NCT01122524, which also lists 3 linked publications.
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 Oct 2011.