Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00002695|
Recruitment Status : Completed
First Posted : April 11, 2003
Last Update Posted : May 19, 2017
RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have been surgically removed, may improve the treatment of patients with cancers of the head and neck.
PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Genetic: DNA stability analysis Genetic: microsatellite instability analysis Genetic: mutation analysis Other: laboratory biomarker analysis|
- Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract.
- Determine the incidence of p53 mutation in this population and its correlation with clinical parameters.
- Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients.
OUTLINE: This is a multicenter study.
Patients undergo standard curative resection and neck node dissection (if appropriate). Specimens are collected from tumor tissue (necrosis-free, if possible), each wound quadrant, any neck disease with clinically negative nodes, and any neck disease with a single positive node for histologic and molecular analysis. Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations. Patients undergo adjuvant radiotherapy and/or chemotherapy, as appropriate for clinical staging and histopathology, at the discretion of the participating clinician.
Patients do not receive results of genetic testing and the results do not affect treatment.
Patients are followed every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total 530 patients will be accrued for this study within 3.5 years.
|Study Type :||Observational|
|Estimated Enrollment :||530 participants|
|Official Title:||CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA|
|Actual Study Start Date :||January 17, 1996|
|Actual Primary Completion Date :||October 18, 2002|
|Actual Study Completion Date :||May 27, 2011|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002695
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Wisconsin|
|CCOP - Green Bay|
|Green Bay, Wisconsin, United States, 54301|
|Study Chair:||Wayne M. Koch, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|