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Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376856
First Posted: June 20, 2011
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • false positive rate of Mediastinal Lymph Node [ Time Frame: 3months ]

Biospecimen Retention:   Samples Without DNA
whole blood for perfoming Quantiferon-TB Gold in tube assay

Enrollment: 33
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
PET/CT and surgical biopsy group
person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
person who performed PET/CT and surgical biposy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376856


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01376856     History of Changes
Other Study ID Numbers: 4-2011-0196
First Submitted: June 16, 2011
First Posted: June 20, 2011
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Yonsei University:
mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases