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Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

Primary Purpose

Tuberculosis, Pulmonary, Latent Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultra low dose chest computed tomography (ULDCT)
Chest X-ray
Interferon-gamma Release Assay (IGRA)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Tuberculosis, Pulmonary

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Close contacts of active pulmonary tuberculosis
  • Family members of active TB patient who has lived together for more than one month, or work colleagues of active TB patient who has been working in the same office for more than 8 months
  • Participants who received explanation of the research plan, understands and writes agreement.

Exclusion Criteria:

  • Vulnerable subjects with mental retardation or severe mental illness
  • Patients who could not receive chest CT
  • Pregnancy
  • Close contacts who diagnosed active pulmonary tuberculosis

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Close contacts of active pulmonary tuberculosis patients

Arm Description

One arm study of conducting ULDCT, chest x-ray, and IGRA

Outcomes

Primary Outcome Measures

Incidence of active pulmonary tuberculosis
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)

Secondary Outcome Measures

Prevalence of active pulmonary tuberculosis at enrollment
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
Prevalence of latent tuberculosis at enrollment
Latent tuberculosis defined by guidelines on the management of latent tuberculosis infection
Change of ultra low dose chest CT findings in latent tuberculosis patients
Serial comparison analysis of CT findings in latent tuberculosis patients who diagnosed latent tuberculosis based on IFN-gamma assay

Full Information

First Posted
June 25, 2017
Last Updated
July 18, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03220464
Brief Title
Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT
Official Title
Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT to Predict Progression to Active Tuberculosis Among Contacts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up
Detailed Description
The early diagnosis of active tuberculosis in close contacts have not yet been established. To evaluate the early detection of active pulmonary tuberculosis using ULDCT, the investigators will establish the observational cohort of close contacts living in the same space with active pulmonary tuberculosis. Participants will visit our center at enrollment, after 3 months, and 12 months and will be received ULDCT, chest X-ray and Interferon-gamma assays at each visit. One chest radiologist will interpret findings of ULDCT and chest X-ray. Patients diagnosed with active tuberculosis will be excluded from the study and treated based on World Health Organization guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary, Latent Tuberculosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Close contacts of active pulmonary tuberculosis patients
Arm Type
Experimental
Arm Description
One arm study of conducting ULDCT, chest x-ray, and IGRA
Intervention Type
Radiation
Intervention Name(s)
Ultra low dose chest computed tomography (ULDCT)
Intervention Description
Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
Intervention Type
Radiation
Intervention Name(s)
Chest X-ray
Other Intervention Name(s)
Chest radiograph
Intervention Description
Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
Intervention Type
Diagnostic Test
Intervention Name(s)
Interferon-gamma Release Assay (IGRA)
Intervention Description
Participants in the study will receive IGRA test at enrollment, after 3-month visit, and after 12-month visit. About 11mL of blood will be drawn from the participants for test of T-SPOT®.TB test and QuantiFERON test.
Primary Outcome Measure Information:
Title
Incidence of active pulmonary tuberculosis
Description
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
Time Frame
For a year
Secondary Outcome Measure Information:
Title
Prevalence of active pulmonary tuberculosis at enrollment
Description
Active pulmonary tuberculosis defined by WHO guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update)
Time Frame
Baseline
Title
Prevalence of latent tuberculosis at enrollment
Description
Latent tuberculosis defined by guidelines on the management of latent tuberculosis infection
Time Frame
Baseline
Title
Change of ultra low dose chest CT findings in latent tuberculosis patients
Description
Serial comparison analysis of CT findings in latent tuberculosis patients who diagnosed latent tuberculosis based on IFN-gamma assay
Time Frame
Baseline, 3-month follow-up, and 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Close contacts of active pulmonary tuberculosis Family members of active TB patient who has lived together for more than one month, or work colleagues of active TB patient who has been working in the same office for more than 8 months Participants who received explanation of the research plan, understands and writes agreement. Exclusion Criteria: Vulnerable subjects with mental retardation or severe mental illness Patients who could not receive chest CT Pregnancy Close contacts who diagnosed active pulmonary tuberculosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Joon Yim, MD, PhD
Phone
82-2-2072-2059
Email
yimjj@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Joon Yim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Joon Yim, MD, PhD
Phone
+82-2-2072-2059
Email
yimjj@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin Hwa Song, MD
Phone
+82-2-2072-2217
Email
songjh86@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
World Health Organization, and Stop TB Initiative (World Health Organization). Treatment of tuberculosis: guidelines. World Health Organization, 2010.
Results Reference
background
PubMed Identifier
25973515
Citation
Guidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK293818/
Results Reference
background
PubMed Identifier
19880906
Citation
Lee SW, Jang YS, Park CM, Kang HY, Koh WJ, Yim JJ, Jeon K. The role of chest CT scanning in TB outbreak investigation. Chest. 2010 May;137(5):1057-64. doi: 10.1378/chest.09-1513. Epub 2009 Oct 31.
Results Reference
result
PubMed Identifier
24788998
Citation
Piccazzo R, Paparo F, Garlaschi G. Diagnostic accuracy of chest radiography for the diagnosis of tuberculosis (TB) and its role in the detection of latent TB infection: a systematic review. J Rheumatol Suppl. 2014 May;91:32-40. doi: 10.3899/jrheum.140100.
Results Reference
result
PubMed Identifier
19383198
Citation
Lew WJ, Jung YJ, Song JW, Jang YM, Kim HJ, Oh YM, Lee SD, Kim WS, Kim DS, Kim WD, Shim TS. Combined use of QuantiFERON-TB Gold assay and chest computed tomography in a tuberculosis outbreak. Int J Tuberc Lung Dis. 2009 May;13(5):633-9.
Results Reference
result
PubMed Identifier
24454900
Citation
Fujikawa A, Fujii T, Mimura S, Takahashi R, Sakai M, Suzuki S, Kyoto Y, Uwabe Y, Maeda S, Mori T. Tuberculosis contact investigation using interferon-gamma release assay with chest x-ray and computed tomography. PLoS One. 2014 Jan 14;9(1):e85612. doi: 10.1371/journal.pone.0085612. eCollection 2014.
Results Reference
result
PubMed Identifier
25265362
Citation
Sloot R, Schim van der Loeff MF, Kouw PM, Borgdorff MW. Risk of tuberculosis after recent exposure. A 10-year follow-up study of contacts in Amsterdam. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1044-52. doi: 10.1164/rccm.201406-1159OC.
Results Reference
result
PubMed Identifier
22936710
Citation
Fox GJ, Barry SE, Britton WJ, Marks GB. Contact investigation for tuberculosis: a systematic review and meta-analysis. Eur Respir J. 2013 Jan;41(1):140-56. doi: 10.1183/09031936.00070812. Epub 2012 Aug 30. Erratum In: Eur Respir J. 2015 Aug;46(2):578.
Results Reference
result

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Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

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