Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00970645 |
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Recruitment Status :
Terminated
(Similar study published results)
First Posted : September 2, 2009
Last Update Posted : July 18, 2011
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Sponsor:
Mayo Clinic
Collaborator:
Medical University of South Carolina
Information provided by:
Mayo Clinic
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Brief Summary:
This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Procedure: Mediastinoscopy/thoracoscopy Procedure: EBUS/EUS | Not Applicable |
This is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. This study requires subjects to agree to the selection of their standard of care procedure. Subjects will be randomized (stratified computer generated randomization stratified y center and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata). Randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. This study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. No additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | March 2011 |
| Actual Study Completion Date : | March 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: traditional mediastinoscopy/thoracoscopy
Traditional Mediastinoscopy used to detect or stage lung cancers.
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Procedure: Mediastinoscopy/thoracoscopy
Mediastinoscopy used to detect/stage lung cancer.
Other Name: Lung biopsy |
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Active Comparator: EBUS/EUS
Minimal invasive technique for staging/detecting lung cancer.
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Procedure: EBUS/EUS
Minimal invasive technique to stage/detect lung cancer.
Other Names:
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Primary Outcome Measures :
- Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques. [ Time Frame: Post operative ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 21 years or greater
- Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection
- Known or suspected non-small cell carcinoma of the lung eligible for resection
- CT scan performed within 45 days prior to evaluation for study participation
- PET scan performed within 45 days prior to evaluation for study participation
Exclusion Criteria:
- Pathologically proven metastatic disease
- History of malignancy within 5 years other than (skin) basal cell carcinoma
- Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter
- Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970645
Locations
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-6300 | |
Sponsors and Collaborators
Mayo Clinic
Medical University of South Carolina
Investigators
| Study Chair: | Brenda Hoffman, M.D. | Medical University of South Carolina | |
| Principal Investigator: | Eric S Edell, M.D. | Mayo Clinic, Rochester, MN | |
| Principal Investigator: | Michael Wallace, M.D. | Mayo Clinic |
| Responsible Party: | Eric S. Edell, M.D., Mayo Clinic, Rochester |
| ClinicalTrials.gov Identifier: | NCT00970645 History of Changes |
| Other Study ID Numbers: |
09-002240 DOD protocol A-12345.8 |
| First Posted: | September 2, 2009 Key Record Dates |
| Last Update Posted: | July 18, 2011 |
| Last Verified: | July 2011 |
Keywords provided by Mayo Clinic:
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Non small cell lung cancer mediastinum endobronchial ultrasound fine needle aspiration endoscopic ultrasound |
mediastinoscopy surgical or minimally invasive evaluation of mediastinum NSCLC |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |