Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
H&N
1 other identifier
observational
N/A
1 country
3
Brief Summary
Collection of tissues for analysis from patients undergoing elective neck dissection. The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2005
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 10, 2017
April 1, 2017
5.9 years
November 30, 2011
April 7, 2017
Conditions
Eligibility Criteria
Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.
You may qualify if:
- All patients with biochemical evidence of squamous cell carcinoma of the head and neck.
You may not qualify if:
- Patients without biomedical evidence of squamous cell carcinoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Biospecimen
Tissue samples from patients undergoing elective neck dissection will be collected. Primary tumors and adjacent normal tissue from unaffected areas will be collected at the time of surgery. All tissue dissection and removal are part of the standard of care for this type of surgical procedure. Remaining resected tissue will be used for research.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
July 1, 2005
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
April 10, 2017
Record last verified: 2017-04