Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation
15 Years
N/A
Both
Head and Neck Cancer
Trial Information
Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation
OBJECTIVES:
Primary
- Characterize, morphologically and molecularly, squamous cell carcinoma of the larynx,
pharynx, or oral cavity in patients without high-risk factors, such as alcohol
consumption, smoking, or occupation.
Secondary
- Study the impact parameters of morphology, molecular characteristics, and genomics on
disease-free survival and overall survival of these patients.
- Study the impact parameters of morphological, molecular, and genomic control in the
tumor.
- Assess, in advanced tumors, the risk of heterogeneity of morphological, molecular, and
genomic control in the tumor.
OUTLINE: This is a multicenter study.
Blood, tumor tissue, and healthy tissue samples are collected before treatment begins.
Patients are followed up every 3 months for 2 years (additional biopsies may be collected).
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the larynx, pharynx, or oral
cavity
- No risk factors of alcohol consumption, smoking, or occupational hazards such as
asbestos, hydrocarbons, paints, nickel, stone dust, or wood dust.
- Must be a life-time non-smoker, not a former smoker
- Measurable disease by RECIST criteria
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- No other serious concomitant medical conditions precluding general anesthesia
- No psychological, familial, social, or geographical reasons that would preclude
follow up
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Tumor response rate by RECIST criteria
Safety Issue:
No
Principal Investigator
Jean-Louis Lefebvre, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
Unspecified
Study ID:
CDR0000635996
NCT ID:
NCT00963326
Start Date:
June 2008
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent verrucous carcinoma of the oral cavity
- stage I verrucous carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- recurrent verrucous carcinoma of the larynx
- stage I verrucous carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- tongue cancer
- Head and Neck Neoplasms
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