Detection of Factor V Leiden G1691A and Factor II (Prothr... | NCT00959504

Studies
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA

NCT00959504

Sponsor

Illumina, Inc.

Status

Completed

Last Update Posted

Jun 9, 2011Estimated

Enrollment

275Actual

Phase

Not provided

Conditions

Detection and Genotyping of Factor V and Factor II Point Mutations

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 13, 2009

First Posted Date

Aug 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2011

Last Update Posted Date

Jun 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

275Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Exclusion Criteria:

There are no applicable exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing.

Sampling Method

Non-Probability Sample