Down SyndromeNCT02430584
Whole Blood Specimen Collection From Pregnant Subjects
An observational study of Down Syndrome and Edwards Syndrome, run by Progenity, Inc. at 1 site in United States.
Trial summary
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Edwards Syndrome, Patau Syndrome
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older
Who may be able to join
- Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
- Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
- Subject is 18 years of age or older
- Subject is at an increased risk for one or more of the following:
- fetal gene and chromosome abnormalities
- congenital fetal infection
- known to possess irregular blood group antigens (subject or father of the baby)
- known to have some other condition amenable to noninvasive prenatal testing
Who cannot join
- Pregnancy is non-viable
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403
About this study
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
Read the detailed description
This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:
- be at an increased risk for fetal genetic abnormalities
- be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.
- possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome
- Being tested
- Observational - no intervention
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational - no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood collection
Measured: One or more monthly clinic visits (≥25 days apart) over 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
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
- Family based
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progenity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430584
- Sponsor's protocol ID
- PRO-101-SAMPLES
- Status last verified
- Sep 2020
- First submitted
- 27 Apr 2015
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Blood Specimen Collection From Pregnant Subjects
- ClinicalTrials.gov ID
- NCT02430584
- Acronym / sponsor ID
- PRO-101-SAMPLES
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Progenity, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 30 Apr 2015 (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.
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
Detailed description
This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:
- be at an increased risk for fetal genetic abnormalities
- be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.
- possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- GENDER: Female ETHNICITY: All ethnicities RACE: All races AGE: Subjects 18 years of age or older
Key inclusion criteria (8 listed)
- Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
- Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
- Subject is 18 years of age or older
- Subject is at an increased risk for one or more of the following:
Key exclusion criteria (1 listed)
- Pregnancy is non-viable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational - no intervention | Other | – |
Primary outcome
Whole blood collection
Time frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Progenity, 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 8 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. 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?
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?
Whole blood collection (time frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks). 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 2020.