QuantiFERON Access Clinical Performance Study Protocol | NCT04243031

Studies
QuantiFERON Access Clinical Performance Study Protocol

NCT04243031

Sponsor

QIAGEN Gaithersburg, Inc

Status

Withdrawn

Last Update Posted

Sep 16, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Tuberculosis (TB)

Interventions

QFT Access

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business Decision

Expanded Access Info

Start Date

Apr 1, 2020Estimated

Primary Completion Date

Aug 1, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 23, 2020

First Posted Date

Jan 27, 2020Actual

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

Sep 14, 2020

Last Update Posted Date

Sep 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects		Those with TB and those without TB.	Device: QFT Access

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QFT Access	Device	Measure of Interferon Gamma	All subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TB Result	QFT Access result compared to the QFT-Plus result (positive, negative)	At time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Be ≥ 18 years of age,
2. Have received no TB treatment or received treatment for less than 14 consecutive days.
3. Provide Informed Consent.

Exclusion Criteria:

1. They do not meet the inclusion criteria,
2. Blood handling was not completed using QFT-Plus
3. Incubation was <16 and >24 hours
4. Improperly collected and/or stored samples per Instructions For Use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants coming to clinic

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided