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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01663584
Other study ID # Natera014
Secondary ID
Status Withdrawn
Phase N/A
First received August 9, 2012
Last updated July 12, 2013
Start date August 2012

Study information

Verified date July 2013
Source Natera, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect blood samples to enable validation of genetic testing for diseases within a multi-disease carrier screening panel. Samples will be collected from adult women or men who have previously tested positive as carriers for various recessive conditions. These are healthy adults who carry a mutation that might place them at increased risk of having a child with a specific genetic disorder. Study participation will be open to adults that were previously tested as part of their routine medical care and where test results demonstrated positive carrier status for a specific genetic disease. Samples will be tested for the disease mutation for which the subjects provides documentation of prior testing.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Individuals who are carriers of an SMN1 deletion consistent with Spinal Muscular Atrophy carrier status and are able to provide documentation of carrier status determined from prior testing

- Able to provide a blood sample

- Pregnant women may be include in the study

Exclusion Criteria:

- Minors under the age of 18 years

- Individuals who are not carriers of a Spinal Muscular Atrophy mutation

- Individuals who are unable to provide documentation of Spinal Muscular Atrophy carrier status.

Study Design

N/A


Intervention

Procedure:
Blood draw


Locations

Country Name City State
United States Natera, Inc San Carlos California

Sponsors (1)

Lead Sponsor Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

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