NCT01412749

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

August 8, 2011

Last Update Submit

June 27, 2013

Conditions

Keywords

registrydatabaseeHNSEndoscopic Head and Neck SurgeryTransoral Endoscopic Surgery TrialTESTmelanomahead and neck surgery

Outcome Measures

Primary Outcomes (1)

  • eHNS Registry

    Registry database using information (data) collected from participants who have had eHNS.

    3 years

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • Medically fit for an endoscopic surgical resection by consensus of MDACC surgical oncology and anesthesia faculty (common best practice criteria).
  • Date of records anticipated to be reviewed would be from March 1, 2011 to June 30, 2013
  • Approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77070, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christ Holsinger, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 9, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations