Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2011-04-30
Brief Summary
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1.1 Primary Objective: To develop a registry database of patients who have had eHNS.
1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).
1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and distant failure and survival following eHNS.
Detailed Description
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The information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed.
This is a registry study evaluating endoscopic head and neck surgery. The data from the surgical resection will be descriptive. Comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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eHNS Participant Registry
Participants diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who are candidates for eHNS.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Medically fit for an endoscopic surgical resection by consensus of MDACC surgical oncology and anesthesia faculty (common best practice criteria).
3. Date of records anticipated to be reviewed would be from March 1, 2011 to June 30, 2013
4. Approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review.
Exclusion Criteria
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christ Holsinger, MD
Role: STUDY_CHAIR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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DR11-0131
Identifier Type: -
Identifier Source: org_study_id