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OpenTrials
Completed

NCT Number: NCT01052688

Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Aneuploidy Chromosome Aberrations Chromosome Disorders Chromosome Duplication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trisomy

Sex eligibility

Female

Study type

Observational

Primary location

Perinatal Care Associates, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy

Treatment and study plan

Maternal blood draw of 30 to 50ml

Other

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.

Primary outcomes

  1. NIPD result compared to standard test results

    Time frame: baseline

    Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Official study title

Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies

Acronym: CHARMM-AP

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2010
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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