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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

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

NCT ID

NCT00963326

First Posted

August 20, 2009

Last Updated

February 25, 2011

Sponsor

Centre Oscar Lambret

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

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

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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