RECRUITING

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Official Title

Collection of Whole Blood Specimens from Pregnant Women At Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma

Quick Facts

Study Start:2011-05
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01429389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * pregnant between 10 and 22 weeks gestation
  2. * 18 years of age or older
  3. * provides signed and dated informed consent
  4. * subject is at increased risk for fetal aneuploidy
  5. * subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
  6. * subject agrees to provide the genetic results of the invasive procedure
  1. * Fetal demise at time of specimen sampling
  2. * Previous sample donation under this protocol

Contacts and Locations

Principal Investigator

Daniel Grosu, MD
STUDY_DIRECTOR
Sequenom, Inc.

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35294
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Sharp-Rees Stealy Medical Group
San Diego, California, 92101
United States
UCSD
San Diego, California, 92121
United States
Women's Health Care Research
San Diego, California, 92123
United States
Specialty Obstetrics of San Diego
San Diego, California, 92130
United States
Reproductive Genetics Institute
Chicago, Illinois, 60602
United States
University of Iowa Health Care
Iowa City, Iowa, 52242
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Spectrum Health
Grand Rapids, Michigan, 49503
United States
The Cooper Health System
Camden, New Jersey
United States
Medical University of South Carolina
Charleston, South Carolina, 29466
United States

Collaborators and Investigators

Sponsor: Sequenom, Inc.

  • Daniel Grosu, MD, STUDY_DIRECTOR, Sequenom, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-05
Study Completion Date2026-03

Study Record Updates

Study Start Date2011-05
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Down syndrome
  • fetal aneuploidy
  • trisomy
  • noninvasive screening test

Additional Relevant MeSH Terms

  • Down Syndrome
  • Fetal Aneuploidy