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OpenTrials
Completed

NCT Number: NCT00482872

Germline Mutations in Patients With Head and Neck Cancer and a Family History of Cancer

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

mutation analysis

Genetic

polymerase chain reaction

Genetic

polymorphism analysis

Genetic

flow cytometry

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Incidence of INK4a-p16 germline mutations

  2. Biologic activity of identified INK4a-p16 germline mutations

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Familial HNSCC Syndrome and p16 Germline Mutations

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2007
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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