Collecting and Storing Tissue Samples From Patients With... | NCT00898300 | Trialant
NCT00898300
Sponsor
Radiation Therapy Oncology Group
Status
Completed
Last Update Posted
Nov 13, 2015Estimated
Enrollment
351Actual
Phase
Not provided
Conditions
Head and Neck Cancer
Interventions
biologic sample preservation procedure
biopsy
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00898300
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RTOG 0514
Secondary IDs
ID
Type
Description
Link
CDR0000460036
Brief Title
Collecting and Storing Tissue Samples From Patients With Head and Neck Cancer
Official Title
Establishment of a Head and Neck Cancer Tissue/Specimen Bank
Acronym
Not provided
Organization
Radiation Therapy Oncology GroupNETWORK
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2005
Primary Completion Date
Jul 2010Actual
Completion Date
Nov 2013Actual
First Submitted Date
May 9, 2009
First Submission Date that Met QC Criteria
May 9, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 11, 2015
Last Update Posted Date
Nov 13, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Radiation Therapy Oncology GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Head and Neck Cancer
Keywords
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
stage I basal cell carcinoma of the lip
stage II basal cell carcinoma of the lip
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
Retention
Enrollment
351Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Patients with confirmed or suspected head and neck cancer
Other: biologic sample preservation procedure
Procedure: biopsy
Interventions
Name
Type
Description
Arm Group Labels
Other Names
biologic sample preservation procedure
Other
Patients with confirmed or suspected head and neck cancer
biopsy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Patients with confirmed or suspected head and neck cancer
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Randal S. Weber, MD
M.D. Anderson Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UAB Comprehensive Cancer Center
Birmingham
Alabama
35294
United States
University of California Davis Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
stage III basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
stage I mucoepidermoid carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
metastatic squamous neck cancer with occult primary
stage I lymphoepithelioma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent basal cell carcinoma of the lip
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent salivary gland cancer
recurrent verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
recurrent metastatic squamous neck cancer with occult primary
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
Samples Without DNA
Description
1. Fresh frozen specimens of normal squamous mucosa, tumors, and pre-malignant lesions of the upper aerodigestive tract. 2. Paraffin-embedded tissue sections from head and neck premalignant and malignant lesions. 3. Serum, plasma and isolate lymphocytes from blood drawn from patients with head and neck cancer. 4. Buccal scrapings and saliva samples from patients with head and neck cancer.
Procedure
Patients with confirmed or suspected head and neck cancer
Sacramento
California
95817
United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs
Colorado
80933
United States
M.D. Anderson Cancer Center at Orlando
Orlando
Florida
32806
United States
Winship Cancer Institute of Emory University
Altanta
Georgia
30322
United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta
Georgia
30303
United States
Emory Crawford Long Hospital
Atlanta
Georgia
30308
United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise
Idaho
83712
United States
John H. Stroger, Jr. Hospital of Cook County
Chicago
Illinois
60612-3785
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
Downers Grove
Illinois
60515-1500
United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey
Illinois
60426
United States
Advocate Lutheran General Cancer Care Center
Park Ridge
Illinois
60068-1174
United States
Methodist Medical Center of Illinois
Peoria
Illinois
61636
United States
Cancer Institute at St. John's Hospital
Springfield
Illinois
62702
United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson
Indiana
46016
United States
St. Vincent Oncology Center
Indianapolis
Indiana
46260
United States
Cancer Center at Ball Memorial Hospital
Muncie
Indiana
47303-3499
United States
Menorah Medical Center
Overland Park
Kansas
66209
United States
Shawnee Mission Medical Center
Shawnee Mission
Kansas
66204
United States
James Graham Brown Cancer Center at University of Louisville
Louisville
Kentucky
40292
United States
Boston University Cancer Research Center
Boston
Massachusetts
02118
United States
Hickman Cancer Center at Bixby Medical Center
Adrian
Michigan
49221
United States
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
48201-1379
United States
Borgess Medical Center
Kalamazoo
Michigan
49001
United States
West Michigan Cancer Center
Kalamazoo
Michigan
49007-3731
United States
Bronson Methodist Hospital
Kalamazoo
Michigan
49007
United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville
Michigan
48144
United States
Community Cancer Center of Monroe
Monroe
Michigan
48162
United States
Mercy Memorial Hospital - Monroe
Monroe
Michigan
48162
United States
Mayo Clinic Cancer Center
Rochester
Minnesota
55905
United States
Truman Medical Center - Hospital Hill
Kansas City
Missouri
64108
United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City
Missouri
64111
United States
St. Joseph Medical Center
Kansas City
Missouri
64114
United States
North Kansas City Hospital
Kansas City
Missouri
64116
United States
Parvin Radiation Oncology
Kansas City
Missouri
64116
United States
CCOP - Kansas City
Kansas City
Missouri
64131
United States
Research Medical Center
Kansas City
Missouri
64132
United States
Heartland Regional Medical Center
Saint Joseph
Missouri
64506
United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney
Nebraska
68848-1990
United States
Methodist Estabrook Cancer Center
Omaha
Nebraska
68114
United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno
Nevada
89502
United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene
New Hampshire
03431
United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756-0002
United States
Monmouth Medical Center
Long Branch
New Jersey
07740-6395
United States
Saint Peter's University Hospital
New Brunswick
New Jersey
08901
United States
Roswell Park Cancer Institute
Buffalo
New York
14263-0001
United States
Beth Israel Medical Center - Petrie Division
New York
New York
10003-3803
United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte
North Carolina
28233-3549
United States
Wayne Memorial Hospital, Incorporated
Goldsboro
North Carolina
27534
United States
Wayne Radiation Oncology
Goldsboro
North Carolina
27534
United States
Rutherford Hospital
Rutherfordton
North Carolina
28139
United States
Wood County Oncology Center
Bowling Green
Ohio
43402
United States
North Coast Cancer Care - Clyde
Clyde
Ohio
43410
United States
Hematology Oncology Center
Elyria
Ohio
44035
United States
Lima Memorial Hospital
Lima
Ohio
45804
United States
Northwest Ohio Oncology Center
Maumee
Ohio
43537-1839
United States
St. Luke's Hospital
Maumee
Ohio
43537
United States
Fisher-Titus Medical Center
Norwalk
Ohio
44857
United States
St. Charles Mercy Hospital
Oregon
Ohio
43616
United States
Toledo Clinic - Oregon
Oregon
Ohio
43616
United States
North Coast Cancer Care, Incorporated
Sandusky
Ohio
44870
United States
Flower Hospital Cancer Center
Sylvania
Ohio
43560
United States
Mercy Hospital of Tiffin
Tiffin
Ohio
44883
United States
Toledo Hospital
Toledo
Ohio
43606
United States
St. Vincent Mercy Medical Center
Toledo
Ohio
43608
United States
Medical University of Ohio Cancer Center
Toledo
Ohio
43614
United States
CCOP - Toledo Community Hospital
Toledo
Ohio
43617
United States
St. Anne Mercy Hospital
Toledo
Ohio
43623
United States
Toledo Clinic, Incorporated - Main Clinic
Toledo
Ohio
43623
United States
Fulton County Health Center
Wauseon
Ohio
43567
United States
Oklahoma University Cancer Institute
Oklahoma City
Oklahoma
73104
United States
Providence Milwaukie Hospital
Milwaukie
Oregon
97222
United States
Providence Cancer Center at Providence Portland Medical Center
Portland
Oregon
97213-2967
United States
Adventist Medical Center
Portland
Oregon
97216
United States
CCOP - Columbia River Oncology Program
Portland
Oregon
97225
United States
Providence St. Vincent Medical Center
Portland
Oregon
97225
United States
Veterans Affairs Medical Center - Portland
Portland
Oregon
97239
United States
Fox Chase Cancer Center - Philadelphia
Philadelphia
Pennsylvania
19111-2497
United States
Albert Einstein Cancer Center
Philadelphia
Pennsylvania
19141
United States
AnMed Cancer Center
Anderson
South Carolina
29621
United States
CCOP - Upstate Carolina
Spartanburg
South Carolina
29303
United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg
South Carolina
29303
United States
M. D. Anderson Cancer Center at University of Texas
Houston
Texas
77030-4009
United States
American Fork Hospital
American Fork
Utah
84003
United States
Sandra L. Maxwell Cancer Center
Cedar City
Utah
84720
United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray
Utah
84157
United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden
Utah
84403
United States
Utah Valley Regional Medical Center - Provo
Provo
Utah
84604
United States
LDS Hospital
Salt Lake City
Utah
84103
United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City
Utah
84106
United States
Dixie Regional Medical Center - East Campus
St. George
Utah
84770
United States
Norris Cotton Cancer Center - North
Saint Johnsbury
Vermont
05819
United States
Fredericksburg Oncology, Incorporated
Fredericksburg
Virginia
22401
United States
Southwest Washington Medical Center Cancer Center
Vancouver
Washington
98668
United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center