Identifcation of Biomarkers for Active Pulmonary Tuberculosis

Identifcation of Biomarkers for Active Pulmonary Tuberculosis Using a Metabolomics Approach: a Prospective Multicenter Study

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.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis; Diagnosis
• Intervention / Treatment: Other: with no intervention, Collect samples

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with active tuberculosis and latent tuberculosis infection

Description

Inclusion Criteria:

• patients with active tuberculosis and latent tuberculosis infection

Exclusion Criteria:

• have other serious health problems

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
active; patients with active tuberculosis	Other: with no intervention, Collect samples; only with observation,there is no need to intervene
latent; patients with latent tuberculosis infection	Other: with no intervention, Collect samples; only with observation,there is no need to intervene
negtive control; healthy volunteers	Other: with no intervention, Collect samples; only with observation,there is no need to intervene

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pintong Huang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: 研2020-556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data (IPD) can be shared after the main unit publish articals
• IPD Sharing Time Frame: by request
• IPD Sharing Access Criteria: by request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No