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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00898742 |
RATIONALE: Studying samples of 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. It may also help doctors predict how will patients respond to treatment.
PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.
Condition | Intervention |
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Head and Neck Cancer |
Genetic: DNA analysis Genetic: microarray analysis Genetic: protein expression analysis Genetic: proteomic profiling Genetic: reverse transcriptase-polymerase chain reaction Other: mass spectrometry |
Study Type: | Observational |
Official Title: | Molecular Signatures of HNSCC in Response to Targeted Therapies |
Estimated Enrollment: | 100 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Christine Chung 615-936-3457 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Christine Chung 615-936-3457 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Study Chair: | Christine Chung, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000583148, VU-VICC-HN-0715, VU-VICC-070668 |
Study First Received: | May 9, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00898742 History of Changes |
Health Authority: | Unspecified |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma |
recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
Nasopharyngeal Carcinoma Laryngeal Carcinoma Cetuximab Carcinoma, Squamous Cell of Head and Neck Squamous Cell Carcinoma Recurrence Carcinoma |
Hypopharyngeal Cancer Metastatic Squamous Neck Cancer With Occult Primary Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell Salivary Gland Diseases |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |