Study of Blood and Tissue Samples From Patients With Lary... | NCT00963326 | Trialant
NCT00963326
Sponsor
Centre Oscar Lambret
Status
Unknown status
Last Update Posted
Feb 28, 2011Estimated
Enrollment
60Estimated
Phase
Not provided
Conditions
Head and Neck Cancer
Interventions
laboratory biomarker analysis
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00963326
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000635996
Secondary IDs
ID
Type
Description
Link
COL-CARIO
2007-11
INCA-RECF0897
ID-RCB-2008-A00300-55
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
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Feb 2011
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2008
Primary Completion Date
Jul 2010Estimated
Completion Date
Not provided
First Submitted Date
Aug 20, 2009
First Submission Date that Met QC Criteria
Aug 20, 2009
First Posted Date
Aug 21, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 25, 2011
Last Update Posted Date
Feb 28, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Centre Oscar LambretOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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).
Conditions Module
Conditions
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
60Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
laboratory biomarker analysis
Other
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Tumor response rate by RECIST criteria
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
15 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jean-Louis Lefebvre, MD
Centre Oscar Lambret
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Centre Oscar Lambret
Recruiting
Lille
59020
France
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006258
Head and Neck Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D014062
Tongue Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D002294
Carcinoma, Squamous Cell
D002277
Carcinoma
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
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