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Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test

NCT01426308 · View on ClinicalTrials.gov ↗

Study Summary

The study will determine the performance of the Infinium HD Test. * The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population. * The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.

Conditions Studied

Study Locations (3)

South Carolina

  • Medical University of South Carolina — Charleston

Texas

  • Baylor College of Medicine — Houston

Utah

  • ARUP Laboratories — Salt Lake City

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2011-08
Est. Completion 2011-11

Sponsor

Illumina

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01426308

The ClinicalTrials.gov registry entry for NCT01426308 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Illumina, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Post-natal Cytogenetics appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01426308 reports 3 study locations spanning 3 distinct geographic areas — top geographies include South Carolina, Texas, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01426308 about?

NCT01426308 is a clinical study titled "Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test". The study will determine the performance of the Infinium HD Test. * The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population. * The secondary objective of the ...

What is the current status of trial NCT01426308?

This trial is currently completed. The enrollment target is 900 participants. The study started on 2011-08. Estimated completion is 2011-11.

What conditions does trial NCT01426308 study?

This clinical trial studies the following conditions: Post-natal Cytogenetics. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01426308?

This trial is sponsored by Illumina, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01426308 being conducted?

This trial has 3 study locations across South Carolina, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial