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

February 25, 2011 updated by: Centre Oscar Lambret

Morphological and Molecular Characterization of Tumors of the Aero-digestive Tract in Patients Who Have no Risk Factors Such as Alcohol, Smoking, or Occupation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumor response rate by RECIST criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Jean-Louis Lefebvre, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000635996
  • 2007-11
  • COL-CARIO
  • INCA-RECF0897
  • ID-RCB-2008-A00300-55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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