TEST: Registry for Endoscopic Head and Neck Surgery (TEST)
Transoral Endoscopic Surgery Trial (TEST): A Registry for Endoscopic Head and Neck Surgery (eHNS)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77070
- UT MD Anderson Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
None.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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eHNS Registry
Tidsram: 3 years
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Registry database using information (data) collected from participants who have had eHNS.
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3 years
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Christ Holsinger, MD, UT MD Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DR11-0131
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