Clinical trial NCT01412749: TEST: Registry for Endoscopic Head and Neck Surgery
Official title: Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Keywords: registry
database
eHNS
Endoscopic Head and Neck Surgery
Transoral Endoscopic Surgery Trial
TEST
melanoma
head and neck surgery
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with head and neck cancer and are a candidate to have endoscopic head and neck surgery (eHNS) for definitive resection of the primary tumor.

Brief summary: The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS.

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: Information from medical records will be collected and entered into the registry database at M. D. Anderson Cancer Center for future research related to cancer.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who, in the opinion of the treating MDACC physician, are candidates for eHNS will be included
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:

None.

Primary outcomes:
measure: eHNS Registry
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Christ Holsinger, MD
role: STUDY_CHAIR
References: