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

NCT ID: NCT00482872

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer

Interventions

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gene expression analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendell G. Yarbrough, MD, FACS

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-HN-0402

Identifier Type: -

Identifier Source: secondary_id

VICC-IRB-040030

Identifier Type: -

Identifier Source: secondary_id

CDR0000546713

Identifier Type: -

Identifier Source: org_study_id

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