NCT01429389 Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
| NCT ID | NCT01429389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sequenom, Inc. |
| Condition | Down Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2011-05 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2011-05 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Eligibility Criteria
Inclusion Criteria: * pregnant between 10 and 22 weeks gestation * 18 years of age or older * provides signed and dated informed consent * subject is at increased risk for fetal aneuploidy * subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis * subject agrees to provide the genetic results of the invasive procedure Exclusion Criteria: * Fetal demise at time of specimen sampling * Previous sample donation under this protocol
Contact & Investigator
Daniel Grosu, MD
STUDY DIRECTOR
Sequenom, Inc.
Frequently Asked Questions
Who can join the NCT01429389 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01429389 currently recruiting?
Yes, NCT01429389 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sequenom, Inc. to inquire about joining.
Where is the NCT01429389 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, San Diego, United States, San Diego, United States and 10 additional locations.
Who is sponsoring the NCT01429389 clinical trial?
NCT01429389 is sponsored by Sequenom, Inc.. The principal investigator is Daniel Grosu, MD at Sequenom, Inc.. The trial plans to enroll 2,000 participants.