- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00482872
Germline Mutations in Patients With Head and Neck Cancer and a Family History of Cancer
Familial HNSCC Syndrome and p16 Germline Mutations
RATIONALE: Studying gene mutations in samples of DNA from patients with head and neck cancer and a family history of cancer may help doctors learn more about the development of cancer in families.
PURPOSE: This clinical trial is studying germline mutations in patients with head and neck cancer and a family history of cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Measure the incidence of p16^INK4a germline mutations in patients with squamous cell carcinoma of the head and neck and a family history of cancer.
- Determine biologic activity of identified p16^INK4a germline mutations.
OUTLINE: DNA specimens are collected for genetic and mutation analysis and examined by PCR and flow cytometry. The activity of cells with p16 mutations is determined by cell cycle arrest functional assay.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma (SCC) of the head and neck
Must have ≥ 1 first-degree relative with any of the following cancers:
- Non-small cell lung cancer
- Melanoma
- Pancreatic cancer
- SCC of the head and neck
- Lymphoma (controls)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of INK4a-p16 germline mutations
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Biologic activity of identified INK4a-p16 germline mutations
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV verrucous carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- 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
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- 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
- salivary gland squamous cell carcinoma
- stage I verrucous carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage I verrucous carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000546713
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-HN-0402
- VICC-IRB-040030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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