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

November 11, 2015 updated by: Radiation Therapy Oncology Group

Establishment of a Head and Neck Cancer Tissue/Specimen Bank

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Comprehensive Cancer Center
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center at Orlando
    • Georgia
      • Altanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, United States, 30308
        • Emory Crawford Long Hospital
      • Atlanta, Georgia, United States, 30303
        • Georgia Cancer Center for Excellence at Grady Memorial Hospital
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612-3785
        • John H. Stroger, Jr. Hospital of Cook County
      • Downers Grove, Illinois, United States, 60515-1500
        • Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Park Ridge, Illinois, United States, 60068-1174
        • Advocate Lutheran General Cancer Care Center
      • Peoria, Illinois, United States, 61636
        • Methodist Medical Center of Illinois
      • Springfield, Illinois, United States, 62702
        • Cancer Institute at St. John's Hospital
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Saint John's Cancer Center at Saint John's Medical Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Oncology Center
      • Muncie, Indiana, United States, 47303-3499
        • Cancer Center at Ball Memorial Hospital
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Shawnee Mission, Kansas, United States, 66204
        • Shawnee Mission Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • James Graham Brown Cancer Center at University of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • Lambertville, Michigan, United States, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Monroe, Michigan, United States, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital - Monroe
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Kansas City, Missouri, United States, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center - Hospital Hill
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, United States, 64114
        • St. Joseph Medical Center
      • Kansas City, Missouri, United States, 64116
        • Parvin Radiation Oncology
      • Saint Joseph, Missouri, United States, 64506
        • Heartland Regional Medical Center
    • Nebraska
      • Kearney, Nebraska, United States, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Omaha, Nebraska, United States, 68114
        • Methodist Estabrook Cancer Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Keene, New Hampshire, United States, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10003-3803
        • Beth Israel Medical Center - Petrie Division
    • North Carolina
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Wood County Oncology Center
      • Clyde, Ohio, United States, 43410
        • North Coast Cancer Care - Clyde
      • Elyria, Ohio, United States, 44035
        • Hematology Oncology Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • St. Luke's Hospital
      • Maumee, Ohio, United States, 43537-1839
        • Northwest Ohio Oncology Center
      • Norwalk, Ohio, United States, 44857
        • Fisher-Titus Medical Center
      • Oregon, Ohio, United States, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care, Incorporated
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, United States, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, United States, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, United States, 43623
        • St. Anne Mercy Hospital
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, United States, 97216
        • Adventist Medical Center
      • Portland, Oregon, United States, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97239
        • Veterans Affairs Medical Center - Portland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Cancer Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
    • Utah
      • American Fork, Utah, United States, 84003
        • American Fork Hospital
      • Cedar City, Utah, United States, 84720
        • Sandra L. Maxwell Cancer Center
      • Murray, Utah, United States, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, United States, 84103
        • LDS Hospital
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Norris Cotton Cancer Center - North
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology, Incorporated
    • Washington
      • Vancouver, Washington, United States, 98668
        • Southwest Washington Medical Center Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed or suspected head and neck cancer

Description

DISEASE CHARACTERISTICS:

  • Confirmed or suspected head and neck cancer

    • Primary site recurrence allowed
  • Potentially eligible for or participating in an active Radiation Therapy Oncology Group treatment clinical trial

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent radiotherapy, drug therapy, biopsy, or surgery allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with confirmed or suspected head and neck cancer
Other: biologic sample preservation procedure
Procedure: biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Establishment of a Head and Neck Cancer Tissue/Specimen Bank
Time Frame: From the start of enrollment to the end of enrollment; enrollment closed at 351 patients
From the start of enrollment to the end of enrollment; enrollment closed at 351 patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Randal S. Weber, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG 0514
  • CDR0000460036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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