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NCT01412749 Clinical Trial

TEST: Registry for Endoscopic Head and Neck Surgery

Head and Neck Cancer Clinical Trial

— TEST  

Official title:
Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01412749
Other study ID # DR11-0131
Secondary ID
Status Terminated
Phase N/A
First received August 8, 2011
Last updated June 27, 2013
Start date April 2011

Study information
Verified date June 2013
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States UT MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary eHNS Registry Registry database using information (data) collected from participants who have had eHNS. 3 years No
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