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

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00482872
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of INK4a-p16 germline mutations
Biologic activity of identified INK4a-p16 germline mutations

Trial Locations

Locations (3)

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States