Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00898300
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is collecting and storing tissue samples from patients with head and neck cancer.

Detailed Description

OBJECTIVES:

* Establish a tissue/specimen bank of biologic specimens collected from patients with proven or suspected head and neck cancer.

* Establish a database to link materials acquisition and pathologic and clinical information on these patients.

* Correlate clinical-pathological findings on these patients with future scientific studies using the patient database.

* Test new hypotheses as they emerge.

OUTLINE: This is a prospective, multicenter study.

Patients enrolled on active Radiation Therapy Oncology Group clinical trials undergo biopsy or surgical resection of head and neck tumors or premalignant lesions at participating institutions. Tissue and other specimens collected at the time of biopsy or surgery are submitted to the Head and Neck Cancer Tissue/Specimen Bank which acts as a central repository for processing, storing, and preserving patient specimens for translational research. Tissue samples include paraffin-embedded blocks or fresh or frozen samples of normal squamous mucosa, tumors, or premalignant lesions of the upper aerodigestive tract. Other specimens for tissue banking include serum, plasma, and lymphocytes isolated from peripheral blood, as well as samples of patient saliva. Cells obtained from tissue bank specimens may also be used to establish cell lines for future research.

PROJECTED ACCRUAL: An unlimited number of specimens will be accrued for this study.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-07
• Study Completion: 2013-11
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of a Head and Neck Cancer Tissue/Specimen Bank	From the start of enrollment to the end of enrollment; enrollment closed at 351 patients

Trial Locations

Locations (98)

UAB Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of California Davis Cancer Center; 🇺🇸 Sacramento, California, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

M.D. Anderson Cancer Center at Orlando; 🇺🇸 Orlando, Florida, United States

Winship Cancer Institute of Emory University; 🇺🇸 Altanta, Georgia, United States

Georgia Cancer Center for Excellence at Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Crawford Long Hospital; 🇺🇸 Atlanta, Georgia, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center; 🇺🇸 Boise, Idaho, United States

John H. Stroger, Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

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