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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963326
First received: August 20, 2009
Last updated: February 25, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Head and Neck Cancer
 Other: laboratory biomarker analysis

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963326

Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Jean-Louis Lefebvre, MD     33-20-295-531     jl-lefebvre@o-lambret.fr    
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Jean-Louis Lefebvre, MD Centre Oscar Lambret
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00963326     History of Changes
Other Study ID Numbers: CDR0000635996, COL-CARIO, 2007-11, INCA-RECF0897, ID-RCB-2008-A00300-55
Study First Received: August 20, 2009
Last Updated: February 25, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013