Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
CHARMM-AP
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
1 other identifier
observational
150
1 country
10
Brief Summary
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedSeptember 20, 2021
April 1, 2020
11.8 years
January 15, 2010
September 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NIPD result compared to standard test results
Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.
baseline
Study Arms (1)
Pregnant Women
Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy.
Interventions
Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.
Eligibility Criteria
Pregnant women who have been definitively diagnosed by amniocentesis, CVS or QF/PCR as carrying a fetus with aneuploidy
You may qualify if:
- Subject is female
- Subject is 18 years or older
- Subject is no less than 8 and no more than 36 weeks gestation
- Subject provides a signed and dated informed consent
- Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
- Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)
You may not qualify if:
- Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (10)
Perinatal Care Associates
Phoenix, Arizona, 85013, United States
St. Joseph's Hospital and medical Center
Phoenix, Arizona, 85013, United States
Sharp Grossmount
San Diego, California, 91944, United States
IGO
San Diego, California, 92121, United States
San Diego Perinatal Center
San Diego, California, 92123, United States
Women's Healthcare at Frost Street
San Diego, California, 92123, United States
Reiter, Hill, Johnson and Nevin
Washington D.C., District of Columbia, 20036, United States
Fetal Diagnostic Institute of the Pacific
Honolulu, Hawaii, 96814, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02902-2499, United States
Biospecimen
Plasma, white blood cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Juan-Sebastian Saldivar, M.D.
Sequenom, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2010
First Posted
January 20, 2010
Study Start
November 1, 2009
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
September 20, 2021
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
Samples and data are used in research and development of a noninvasive prenatal test. However, sample data used in publications will be shared as per requirements of the journal.