Solitary Pulmonary NoduleNCT01149187
Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
An observational study of Solitary Pulmonary Nodule, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies. Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule
- How many people
- 400 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2010to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among the inpatients who got percutaneous needle biopsy for pulmonary nodule during the study periods are going to be enrolled.
Who may be able to join
- Age> 18 years
- in patients with solitary pulmonary nodule
- who had percutaneous needle biopsy for diagnosis of lung nodule
Who cannot join
- patients who do not agree the study enrollment
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Young Whan Kim
Seoul, 110-744
Young Whan Kim, MD, 82-2-2072-2856, ywkim@snu.ac.kr
Hyo-Jeong Lim, MD, 82-2-2072-2957, lregulus38@gmail.com
- Recruiting
Young Whan Kim
Seoul, 110-744
Young Whan Kim, MD, 82-2-2072-2856, ywkim@snu.ac.kr
Hyo-Jeong Lim, MD, 82-2-2072-2957, lregulus38@gmail.com
About this study
Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.
Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.
The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.
Read the detailed description
Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008.
The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.
- Conditions
- Solitary Pulmonary Nodule
- Medical subject headings
- Solitary Pulmonary Nodule
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 |
|---|---|---|
| IGRA in solitary pulmonary nodules | Inpatients who undergo percutaneous needle biopsy for diagnosis of pulmonary nodules in Seoul National University hospital for six months are going to be included. Patients who are not tolerable for PCNB or do not agree the enrollment of study will be excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of the interferon-gamma release assay
the result of the interferon-gamma release assay is reported in three different categories as positive, negative or indeterminate. We want to know whether the positive rate of the interferon-gamma release asssay would be significantly different according to the pathologic diagnosis of lung nodules confirmed by percutaneous needle biopsy.
Measured: within 36hrs after blood sampling
Secondary outcomes (1)
Positive rate of the Tuberculin skin test
We will conduct Tuberculin skin test and evaluate the whether the positive rate of the Tuberculin skin test would be different according to the pathologic diagnosis of lung nodules confirmed by percutaneous needle biopsy.
Measured: 48hours after tuberculin skin test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149187
- Sponsor's protocol ID
- SeoulNUH-IGRA-01
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT01149187
- Acronym / sponsor ID
- SeoulNUH-IGRA-01
- Conditions
- Solitary Pulmonary Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 23 Jun 2010 (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.
Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.
Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.
The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.
Detailed description
Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008.
The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGRA in solitary pulmonary nodules | – | –Inpatients who undergo percutaneous needle biopsy for diagnosis of pulmonary nodules in Seoul National University hospital for six months are going to be included. Patients who are not tolerable for PCNB or do not agree the enrollment of study will be excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among the inpatients who got percutaneous needle biopsy for pulmonary nodule during the study periods are going to be enrolled.
Key inclusion criteria (3 listed)
- Age> 18 years
- in patients with solitary pulmonary nodule
- who had percutaneous needle biopsy for diagnosis of lung nodule
Key exclusion criteria (1 listed)
- patients who do not agree the study enrollment
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
Positive rate of the interferon-gamma release assay
Time frame: within 36hrs after blood sampling
the result of the interferon-gamma release assay is reported in three different categories as positive, negative or indeterminate. We want to know whether the positive rate of the interferon-gamma release asssay would be significantly different according to the pathologic diagnosis of lung nodules confirmed by percutaneous needle biopsy.
1 secondary outcome
Positive rate of the Tuberculin skin test
Time frame: 48hours after tuberculin skin test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule, run by Seoul National University Hospital at 2 sites 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Whan Kim, MD (82-2-2072-2856, ywkim@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of the interferon-gamma release assay (time frame: within 36hrs after blood sampling). 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 23 Jun 2010.