Non Small Cell LungNCT00577746
Clinical Impact of EUS in Staging NSCLC
An observational study of Non Small Cell Lung, run by Indiana University at 1 site in United States.
Trial summary
The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung
- How many people
- 110 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: Potentially resectable lung cancer subjects see at thoracic oncology clinics and gastroenterolgy lab.
Who may be able to join
- Any subject with presumed or known potentially resectable NSCLC
- Due to the nature of NSCLC, children (<18 year of age) will not be considered
- Men, women, and minorities
- Subjects must be able to safely undergo conscious sedation for the EUS procedure
- Subjects must be surgical candidates
- Subjects must not have an uncorrectable coagulopathy and must be able to refrain from the used of aspirin one week prior to the EUS
- Patient must provide signed written informed consent
Who cannot join
- Subjects with a history of previously treated lung, head \& neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
- Uncorrectable coagulopathy
- Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
- Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
- Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
- Evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric illness that would preclude adequate compliance with this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center; Clarian Health
Indianapolis, Indiana, 46202
About this study
Official title: The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.
- Conditions
- Non Small Cell Lung
- Keywords
- Non Small Cell Lung
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 for treatment for their lung cancer. | |
| no surgery | The subjects who did not go to surgery for treatment of their lung cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the accuracy of EUS in staging NSCLC
Measured: at the end of the study
Secondary outcomes (3)
Measure 5-year survival
Measured: 5 years
Determine the cost benefit of EUS in staging NSCLC
Measured: at the end of the study
Measure quality of life in patients that undergo surgery
Measured: at the end of the study
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 Non Small Cell LungStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Richard L. Roudebush VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Julia LeBlanc, MD, MPH, Principal investigator, Indiana University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577746
- Sponsor's protocol ID
- 0306-37
- Other IDs
- IRB # 0306-37
- Status last verified
- Sep 2014
- First submitted
- 19 Dec 2007
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00577746
- Acronym / sponsor ID
- 0306-37
- Conditions
- Non Small Cell Lung
- Keywords
- Non Small Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Richard L. Roudebush VA Medical Center
- 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 goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | – | –Those subjects who went to surgery for treatment for their lung cancer. |
| no surgery | – | –The subjects who did not go to surgery for treatment of their lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially resectable lung cancer subjects see at thoracic oncology clinics and gastroenterolgy lab.
Key inclusion criteria (7 listed)
- Any subject with presumed or known potentially resectable NSCLC
- Due to the nature of NSCLC, children (<18 year of age) will not be considered
- Men, women, and minorities
- Subjects must be able to safely undergo conscious sedation for the EUS procedure
- Subjects must be surgical candidates
Key exclusion criteria (6 listed)
- Subjects with a history of previously treated lung, head \& neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
- Uncorrectable coagulopathy
- Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
- Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
- Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
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
Determine the accuracy of EUS in staging NSCLC
Time frame: at the end of the study
3 secondary outcomes
Measure 5-year survival
Time frame: 5 years
Determine the cost benefit of EUS in staging NSCLC
Time frame: at the end of the study
Measure quality of life in patients that undergo surgery
Time frame: at the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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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 Medical Center
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 Non Small Cell Lung, 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 5 Sep 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the accuracy of EUS in staging NSCLC (time frame: at the end of the study). 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 5 Sep 2014.