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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01376856
Other study ID # 4-2011-0196
Secondary ID
Status Terminated
Phase N/A
First received June 16, 2011
Last updated June 1, 2013
Start date June 2011
Est. completion date November 2011

Study information

Verified date June 2013
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

The purpose of this study is to analyze pathologic and radiologic characteristics of mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and assess relationship between false positive mediastinal lymph node and TB/latent TB.


Recruitment information / eligibility

Status Terminated
Enrollment 33
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- age 20-75, men and women

- person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Exclusion Criteria:

- age < 20

- person who don't agree with enrollment

- illiterate

- person who is diagnosed as active tuberculosis now

- person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)

- pregnant woman

- person who is treated as active tuberculosis

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary false positive rate of Mediastinal Lymph Node 3months No
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