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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02497079 |
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Date of registration:
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08/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnostic Accuracy of Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples
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Scientific title:
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Comparison of the Diagnostic Accuracy of Nested and Real-time Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples in Patients With Isolated Intrathoracic Lymphadenopathy |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02497079 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jung Seop Eom, Master |
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Address:
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Telephone:
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+821020810859 |
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Email:
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ejspulm@gmail.com |
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Affiliation:
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Name:
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Jeong Ha Mok, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Hospital |
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Name:
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Jung Seop Eom Eom, Master |
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Address:
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Telephone:
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82-01-2081-0859 |
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Email:
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ejspulm@gmail.com |
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Affiliation:
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Name:
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Jung Seop Eom, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pusan National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with isolated intrathoracic lymphadenopathy
Exclusion Criteria:
- Suspicion of primary lung cancer on CT or PET scan
- Suspicion of pulmonary tuberculosis on CT or PET scan
- Suspicion of sarcoidosis of lung parenchyma on CT or PET scan
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sarcoidosis
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Lymphadenopathy
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Tuberculosis
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Intervention(s)
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Device: Nested PCR for formalin-fixed tissues
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Device: Real-time PCR for fresh tissues
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Device: Nested PCR for fresh tissues
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Primary Outcome(s)
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Number of participants who detected each polymerase chain reactions for Mycobacterium tuberculosis
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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