Identifcation of Biomarkers for Active Pulmonary Tubercul... | NCT04490746

Studies
Identifcation of Biomarkers for Active Pulmonary Tuberculosis

NCT04490746

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jul 29, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Tuberculosis
Diagnosis

Interventions

with no intervention, Collect samples

Countries

China

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Jul 26, 2020

First Submission Date that Met QC Criteria

Jul 26, 2020

First Posted Date

Jul 29, 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

Jul 26, 2020

Last Update Posted Date

Jul 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.

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

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
active	patients with active tuberculosis	Other: with no intervention, Collect samples
latent	patients with latent tuberculosis infection	Other: with no intervention, Collect samples
negtive control	healthy volunteers	Other: with no intervention, Collect samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
with no intervention, Collect samples	Other	only with observation,there is no need to intervene	active latent negtive control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
metabolic product	features up-regulated or down-regulated	24 hours after sampling

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with active tuberculosis and latent tuberculosis infection

Exclusion Criteria:

have other serious health problems

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

patients with active tuberculosis and latent tuberculosis infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yajing Liu	Contact	18358152521		liuyajingyyyyy@126.com

Overall Officials

Name	Affiliation	Role
Pintong Huang	Second Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	0571	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

individual participant data (IPD) can be shared after the main unit publish articals

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

by request

Access Criteria

by request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D004194	Disease

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