Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies (CHARMM-AP)

September 16, 2021 updated by: Sequenom, Inc.

Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85013
        • Perinatal Care Associates
    • California
      • San Diego, California, United States, 92123
        • San Diego Perinatal Center
      • San Diego, California, United States, 91944
        • Sharp Grossmount
      • San Diego, California, United States, 92121
        • IGO
      • San Diego, California, United States, 92123
        • Women's Healthcare at Frost Street
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Reiter, Hill, Johnson and Nevin
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Fetal Diagnostic Institute of the Pacific
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Rhode Island
      • Providence, Rhode Island, United States, 02902-2499
        • Women and Infants Hospital of Rhode Island

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.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who have been definitively diagnosed by amniocentesis, CVS or QF/PCR as carrying a fetus with aneuploidy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant Women
Pregnant women who have been definitively diagnosed as carrying a fetus with aneuploidy.
Other: Maternal blood draw of 30 to 50ml
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Investigators

  • Study Director: Juan-Sebastian Saldivar, M.D., 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 Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

August 31, 2021

Study Completion (ACTUAL)

August 31, 2021

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (ESTIMATE)

January 20, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNM T21-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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