Down SyndromeNCT02226315
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
An observational study of Down Syndrome and Edwards Syndrome, run by Sequenom, Inc. at 1 site in United States.
Trial summary
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Down Syndrome, Edwards Syndrome, Patau Syndrome
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2015
- 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: Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).
Who may be able to join
- Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
- Subject was 18 years of age or older at the time of NIPT;
- Subject provides signed and dated informed consent in English;
Who cannot join
- Subjects' treating physician is not located in the United States.
Trial locations and contacts
1 site in 1 country.
United States1 site
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218
About this study
Official title: A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome
- Keywords
- noninvasive prenatal testing
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Turner 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 |
|---|---|---|
| Multiple gestations | Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient
Measured: Subjects contacted within 3 years after pregnancy is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Slow enrollment of eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Friends Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Porreco, MD, Principal investigator, Presbyterian/St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226315
- Sponsor's protocol ID
- SQNM-T21-109
- Status last verified
- Sep 2015
- First submitted
- 20 Aug 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy
- ClinicalTrials.gov ID
- NCT02226315
- Acronym / sponsor ID
- SQNM-T21-109
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome
- Keywords
- noninvasive prenatal testing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment of eligible subjects
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Friends Research Institute, Inc.
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Aug 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 will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple gestations | – | –Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).
Key inclusion criteria (3 listed)
- Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
- Subject was 18 years of age or older at the time of NIPT;
- Subject provides signed and dated informed consent in English;
Key exclusion criteria (1 listed)
- Subjects' treating physician is not located in the United States.
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
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
Time frame: Subjects contacted within 3 years after pregnancy is completed
Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient
Results and safety
The study was stopped early (reason given: Slow enrollment of eligible subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
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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.
Richard Porreco, MD principal investigator
Presbyterian/St. Luke's Medical Center
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 Down Syndrome and Edwards Syndrome, run by Sequenom, Inc. 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 3 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: stopped early, as of the sponsor's last update on 17 Sep 2015. 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 was stopped early (reason given: Slow enrollment of eligible subjects). Results are not available in the source record.
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?
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay (time frame: Subjects contacted within 3 years after pregnancy is completed). 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 17 Sep 2015.