Lung CancerNCT01376856
Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection
An observational study of Lung Cancer, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: person who performed PET/CT and surgical biposy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer
- Keywords
- mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
false positive rate of Mediastinal Lymph Node
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376856
- Sponsor's protocol ID
- 4-2011-0196
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01376856
- Acronym / sponsor ID
- 4-2011-0196
- Conditions
- Lung Cancer
- Keywords
- mediastinal lymph node with false positive FDG PET/CT results in lung cancer staging
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- person who performed PET/CT and surgical biposy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
false positive rate of Mediastinal Lymph Node
Time frame: 3months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
false positive rate of Mediastinal Lymph Node (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.