Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Brief Summary

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The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.

Detailed Description

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Conditions

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Genetic Disorders

Keywords

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Multiple genetic conditions will be studied

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Must be able to donate at least 10 mL of whole blood
* Must be able to provide consent, or parental consent and patient assent (if applicable)
* Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)

Exclusion Criteria

* Unable to donate at least 10 mL of whole blood
* Unable to provide consent, or parental consent and patient assent (if applicable)
* Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Central Contacts

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Lynda Hague

Role: CONTACT

Phone: 224-361-7101

Email: [email protected]

Andrew Hiar

Role: CONTACT

Phone: 224-361-7056