Non-Invasive Screening for Fetal Aneuploidy

Status unconfirmed

Conditions studied: Down Syndrome, Edwards Syndrome

In brief

The purpose of this study is to detect whole chromosome abnormalities in maternal blood.

Key facts

Study ID

NCT02317965

Run by

Progenity, Inc.

People needed

340

Starts

2015-03-01

Expected to finish

2018-11-01

Last updated by the study team

2018-08-28

Who can join

Age: 18 and older, up to 54. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• • Subject is a pregnant woman 18-54 years of age at 8-22 weeks' gestation inclusive;
• Subject has additional risk indicators for fetal chromosome aneuploidy, including one or more of the following:
• Maternal age > 34 years at the estimated date of delivery;
• Positive serum screening test suggesting fetal aneuploidy;
• Previous positive noninvasive cfDNA test is acceptable
• Fetal ultrasound abnormality suggesting fetal chromosomal abnormality;
• Personal or family history of Down syndrome or other chromosomal aneuploidy.
• Willing to provide written informed consent
• Willing to be re-contacted subsequently for additional information and/or testing if necessary.

You may not qualify if…

• Subjects will not be entered into this study if they meet the following criteria:
• Fetal demise at the time of the blood draw;
• Previous specimen donation under this protocol;
• Unwilling or lacks the capacity to provide informed consent or to comply with study procedures;
• Currently under treatment for cancer
• Any history of autoimmune disease
• Any pelvic mass
• Previous history of radiation to pelvis
• Any history or current evidence of a twin demise at any gestational age.

Where it is running

• Obstetrix Medical Group of California — Campbell, California, United States
• Long Beach Memorial Medical Ctr - 2nd Floor Perinatal — Long Beach, California, United States
• OBX Med. Group. of Colorado - Pres/St Luke's Clinic — Denver, Colorado, United States
• OBX Med. Group. of Colorado - Antepartum Testing Unit @ Rose Medical Center — Denver, Colorado, United States
• OBX Med. Group. of Colorado - Perinatal Resource Ctr @ Swedish Med Ctr. — Englewood, Colorado, United States
• OBX Med. Group. of Colorado - Skyridge — Lone Tree, Colorado, United States
• Regional Obstetrical Consultants — Chattanooga, Tennessee, United States
• Obstetrix Medical Group of Texas — Fort Worth, Texas, United States
• Obstetrix Medical Group of Houston — The Woodlands, Texas, United States
• Obstetrix, Medical Group of Washington, Inc. - Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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