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Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
laboratory biomarker analysis
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar LambretRecruiting

Outcomes

Primary Outcome Measures

Tumor response rate by RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
August 20, 2009
Last Updated
February 25, 2011
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT00963326
Brief Title
Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer
Official Title
Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation
Study Type
Observational

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Oscar Lambret

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Tumor response rate by RECIST criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Lefebvre, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Lefebvre, MD
Phone
33-20-295-531
Email
jl-lefebvre@o-lambret.fr

12. IPD Sharing Statement

Learn more about this trial

Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer

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