Germline Mutations in Patients With Head and Neck Cancer and a Family History of Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00482872
First received: June 4, 2007
Last updated: February 26, 2010
Last verified: February 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: flow cytometry Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Familial HNSCC Syndrome and p16 Germline Mutations |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Incidence of INK4a-p16 germline mutations [ Designated as safety issue: No ]
- Biologic activity of identified INK4a-p16 germline mutations [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482872
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | Wendell G. Yarbrough, MD, FACS | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00482872 History of Changes |
| Other Study ID Numbers: | CDR0000546713, VU-VICC-HN-0402, VICC-IRB-040030 |
| Study First Received: | June 4, 2007 |
| Last Updated: | February 26, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity |
metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary stage I squamous cell carcinoma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx 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 III squamous cell carcinoma of the paranasal sinus and nasal cavity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013