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

NCT ID: NCT00898300

Last Updated: 2015-11-13

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

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with confirmed or suspected head and neck cancer

biologic sample preservation procedure

Intervention Type OTHER

biopsy

Intervention Type PROCEDURE

Interventions

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biologic sample preservation procedure

Intervention Type OTHER

biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-1

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent radiotherapy, drug therapy, biopsy, or surgery allowed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randal S. Weber, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Site Status

Winship Cancer Institute of Emory University

Altanta, Georgia, United States

Site Status

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Site Status

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Site Status

Saint John's Cancer Center at Saint John's Medical Center

Anderson, Indiana, United States

Site Status

St. Vincent Oncology Center

Indianapolis, Indiana, United States

Site Status

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status

Boston University Cancer Research Center

Boston, Massachusetts, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, United States

Site Status

Community Cancer Center of Monroe

Monroe, Michigan, United States

Site Status

Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States

Site Status

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

St. Joseph Medical Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Parvin Radiation Oncology

Kansas City, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Site Status

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Site Status

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Beth Israel Medical Center - Petrie Division

New York, New York, United States

Site Status

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Site Status

Rutherford Hospital

Rutherfordton, North Carolina, United States

Site Status

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

North Coast Cancer Care - Clyde

Clyde, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

St. Luke's Hospital

Maumee, Ohio, United States

Site Status

Fisher-Titus Medical Center

Norwalk, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, Ohio, United States

Site Status

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Site Status

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Site Status

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Adventist Medical Center

Portland, Oregon, United States

Site Status

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Veterans Affairs Medical Center - Portland

Portland, Oregon, United States

Site Status

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

AnMed Cancer Center

Anderson, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Site Status

American Fork Hospital

American Fork, Utah, United States

Site Status

Sandra L. Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

Site Status

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Site Status

Norris Cotton Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Site Status

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CDR0000460036

Identifier Type: -

Identifier Source: secondary_id

RTOG 0514

Identifier Type: -

Identifier Source: org_study_id

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