Development and Application of Rapid Nucleic Acid Diagnos... | NCT01322685

Studies
Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens

NCT01322685

Sponsor

Taipei Medical University WanFang Hospital

Status

Unknown status

Last Update Posted

Mar 24, 2011Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Tuberculosis
Lung Cancer

Interventions

Not provided

Countries

Taiwan

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

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Not provided

Completion Date

Jun 2011Estimated

First Submitted Date

Mar 23, 2011

First Submission Date that Met QC Criteria

Mar 23, 2011

First Posted Date

Mar 24, 2011Estimated

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

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to study the Development and Application of Rapid Nucleic Acid Diagnostic Kits for Clinical Specimens. Subjects are divided into two groups which are health group and Tuberculosis or lung cancer group in order to compare with the difference.

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

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Health group: between 17 to 90 years old
Tuberculosis group: people who are tuberculosis or lung cancer patients and between 17 to 90 years old

Exclusion Criteria:

Women subjects are before or after the period within two days

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Health people Tuberculosis or lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuo-Sheng Hung	Taipei Medical University WanFang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Medical University - WanFang Hospital		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D008175	Lung Neoplasms

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

Label	Type	Description	Intervention Names
Health Group
Tuberculosis Group		Tuberculosis or lung cancer group