Rhesus D GenotypeIRISNCT01054716
Evaluation of a Noninvasive Fetal RHD Genotyping Test
An observational study of Rhesus D Genotype, run by Sequenom, Inc. at 5 sites in United States.
Trial summary
This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Rhesus D Genotype
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2009to Nov 2010
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
Who may be able to join
- Subject is 18-64 years of age
- Subject is female
- Subject is pregnant
- Subject is RhD negative
- Subject is between 10 and 28 weeks gestation
- Subject provides informed consent
- Subject agrees to provide neonatal RHD and sex outcome
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Spectrum Health Research
Grand Rapids, Michigan, 49503
Sharp Grossmont Hospital
San Diego, California, 91944
West Coast OBGYN
San Diego, California, 92123
Women's Health Care, Inc
San Diego, California, 92123
Scripps Hospitals (5 San Diego locations)
San Diego, California, 92130
About this study
This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.
- Conditions
- Rhesus D Genotype
- Keywords
- RhD negative, RhD disease, fetal nucleic acid, fetal DNA, cell free fetal DNA, Fetal RHD genotype
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal RHD determination from maternal whole blood
Measured: Between 10 and 28 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhesus D GenotypeStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sequenom Center for Molecular Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054716
- Sponsor's protocol ID
- SQNM-RHD-105
- Acronym
- IRIS
- Status last verified
- Sep 2011
- First submitted
- 20 Jan 2010
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Noninvasive Fetal RHD Genotyping Test
- ClinicalTrials.gov ID
- NCT01054716
- Acronym / sponsor ID
- IRIS / SQNM-RHD-105
- Conditions
- Rhesus D Genotype
- Keywords
- RhD negative, RhD disease, fetal nucleic acid, fetal DNA, cell free fetal DNA, Fetal RHD genotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sequenom Center for Molecular Medicine
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Jan 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.
This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
Key inclusion criteria (7 listed)
- Subject is 18-64 years of age
- Subject is female
- Subject is pregnant
- Subject is RhD negative
- Subject is between 10 and 28 weeks gestation
Key exclusion criteria (1 listed)
- None
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
Fetal RHD determination from maternal whole blood
Time frame: Between 10 and 28 weeks gestation
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 5 Sep 2011.
Related trials for Rhesus D Genotype
Active, not recruitingObservational study
Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
Rhesus D Genotype, Pregnancy
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhesus D Genotype, run by Sequenom, Inc. at 5 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 7 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 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Fetal RHD determination from maternal whole blood (time frame: Between 10 and 28 weeks gestation). 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 5 Sep 2011.