NCT01376856

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

June 16, 2011

Last Update Submit

June 1, 2013

Conditions

Keywords

mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging

Outcome Measures

Primary Outcomes (1)

  • false positive rate of Mediastinal Lymph Node

    3months

Study Arms (1)

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 Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood for perfoming Quantiferon-TB Gold in tube assay

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations