Lung CancerNCT00578084
Lung Cancer Location: a Repository
An observational study of Lung Cancer, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2013
- 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: Subjects with known or suspected lung cancer will be identified by referral to the thoracic surgeon or ultrasonographer at the Veterans Affairs Hospital or Indiana University Medical Center.
Who may be able to join
- Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
- Subjects with a prior history of lung cancer
- Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer
Who cannot join
- Altered mental status that would prohibit the giving and understanding of informed consent
- Dementia
- Psychiatric illness that would preclude adequate compliance with communication for this protocol
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Clarian/IUPUI: University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Lung Cancer Location: A Prospective Repository
The purpose of this repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.
- Conditions
- Lung Cancer
- 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 |
|---|---|---|
| surgery | those subjects who went to surgery to treat their lung cancer | |
| no surgery | those subjects who did not go to surgery for their lung cancer | |
| NSCLC | subjects with NSCLC | |
| Small cell lung cancer | those with small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location
Measured: ongoing-database
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJun 2006
- Primary completionJul 2013
- Study completionSep 2013
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 Indiana 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia LeBlanc, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578084
- Sponsor's protocol ID
- 0604-76
- Other IDs
- IRB # 0604-76
- Status last verified
- Sep 2013
- First submitted
- 19 Dec 2007
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Location: A Prospective Repository
- ClinicalTrials.gov ID
- NCT00578084
- Acronym / sponsor ID
- 0604-76
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Dec 2007 (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 repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| surgery | – | –those subjects who went to surgery to treat their lung cancer |
| no surgery | – | –those subjects who did not go to surgery for their lung cancer |
| NSCLC | – | –subjects with NSCLC |
| Small cell lung cancer | – | –those with small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with known or suspected lung cancer will be identified by referral to the thoracic surgeon or ultrasonographer at the Veterans Affairs Hospital or Indiana University Medical Center.
Key inclusion criteria (3 listed)
- Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
- Subjects with a prior history of lung cancer
- Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer
Key exclusion criteria (4 listed)
- Altered mental status that would prohibit the giving and understanding of informed consent
- Dementia
- Psychiatric illness that would preclude adequate compliance with communication for this protocol
- Prisoners
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
examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location
Time frame: ongoing-database
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 8 Oct 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.
Julia LeBlanc, MD, MPH principal investigator
Indiana University
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 Indiana University at 1 site in United States.
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 4 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 8 Oct 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 United States. 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?
examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location (time frame: ongoing-database). 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 8 Oct 2013.