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

Head and Neck Cancer Clinical Trial

Official title:

Establishment of a Head and Neck Cancer Tissue/Specimen Bank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898300
• Other study ID #: RTOG 0514
• Secondary ID: CDR0000460036
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 11, 2015
• Start date: September 2005
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: November 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• biologic sample preservation procedure

Procedure:
• biopsy

Locations

Country	Name	City	State
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Winship Cancer Institute of Emory University	Altanta	Georgia
United States	American Fork Hospital	American Fork	Utah
United States	AnMed Cancer Center	Anderson	South Carolina
United States	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Georgia Cancer Center for Excellence at Grady Memorial Hospital	Atlanta	Georgia
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Wood County Oncology Center	Bowling Green	Ohio
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	North Coast Cancer Care - Clyde	Clyde	Ohio
United States	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Hematology Oncology Center	Elyria	Ohio
United States	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	St. Vincent Oncology Center	Indianapolis	Indiana
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Parvin Radiation Oncology	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lima Memorial Hospital	Lima	Ohio
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	St. Luke's Hospital	Maumee	Ohio
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Community Cancer Center of Monroe	Monroe	Michigan
United States	Mercy Memorial Hospital - Monroe	Monroe	Michigan
United States	Cancer Center at Ball Memorial Hospital	Muncie	Indiana
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Beth Israel Medical Center - Petrie Division	New York	New York
United States	Fisher-Titus Medical Center	Norwalk	Ohio
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Toledo Clinic - Oregon	Oregon	Ohio
United States	M.D. Anderson Cancer Center at Orlando	Orlando	Florida
United States	Menorah Medical Center	Overland Park	Kansas
United States	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Adventist Medical Center	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Renown Institute for Cancer at Renown Regional Medical Center	Reno	Nevada
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Norris Cotton Cancer Center - North	Saint Johnsbury	Vermont
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Shawnee Mission Medical Center	Shawnee Mission	Kansas
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
United States	Fulton County Health Center	Wauseon	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No