NCT04490746

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 26, 2020

Last Update Submit

July 26, 2020

Conditions

TuberculosisDiagnosis

Outcome Measures

Primary Outcomes (1)

  • metabolic product

    features up-regulated or down-regulated

    24 hours after sampling

Study Arms (3)

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

with no intervention, Collect samplesOTHER

only with observation,there is no need to intervene

activelatentnegtive control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with active tuberculosis and latent tuberculosis infection

You may qualify if:

  • patients with active tuberculosis and latent tuberculosis infection

You may not qualify if:

  • have other serious health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 0571, China

Location

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pintong Huang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yajing Liu

CONTACT

18358152521liuyajingyyyyy@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2020

First Posted

July 29, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
by request
Access Criteria
by request

Locations

CN(1)