Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

• Sponsor: Tongji University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04148053
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 31.3

Study Details

Study Description

Brief Summary

Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis Infection	Diagnostic Test: TB-antigen responsive T cell markers

Detailed Description

The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active TB Subjects met the following: Either Pulmonary or Extra-pulmonary tuberculosis patients TB Bacteriological evidence obtained by culture or Xpert MTB/RIF from at least 1 specimen.	Diagnostic Test: TB-antigen responsive T cell markers; A blood test including a series of T cell markers which are responsive to TB antigens
Latent TB Subjects met the following: TB Contact in history. Chest X-ray suggestive of non-TB. without any symptoms suggestive of TB. TST and/or IGRA positive.	Diagnostic Test: TB-antigen responsive T cell markers; A blood test including a series of T cell markers which are responsive to TB antigens

Outcome Measures

Primary Outcome Measures

1. Positive rate and negative rate [2-3 month after sampling]

   Evaluation of the positive rate and negative rate for each T cell marker

2. Receiver operating characteristic curve [2-3 month after sampling]

   The AUC of each T cell marker will be analyzed and compared

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• any patients suspicious of TB infection

• TB culture and Xpert test required

• Chest X-ray required

Exclusion Criteria:

• anti-TB therapy before the sample collection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Pulmonary Hospital	Shanghai	Shanghai	China	200123

Sponsors and Collaborators

• Tongji University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caicun Zhou, Director, Department of Thoracic Oncology, Tongji University
• ClinicalTrials.gov Identifier: NCT04148053
• Other Study ID Numbers: CTB18001
• First Posted: Nov 1, 2019
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tuberculosis; Latent Tuberculosis

Study Results

No Results Posted as of Nov 1, 2019