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

• Sponsor: Radiation Therapy Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00898300
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 351
• Locations: 98
• Duration (Months): 98
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: biologic sample preservation procedure; Procedure: biopsy

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 Design

• Study Type: Observational
• Actual Enrollment: 351 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Establishment of a Head and Neck Cancer Tissue/Specimen Bank
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	University of California Davis Cancer Center	Sacramento	California	United States	95817
3	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
4	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
5	Winship Cancer Institute of Emory University	Altanta	Georgia	United States	30322
6	Georgia Cancer Center for Excellence at Grady Memorial Hospital	Atlanta	Georgia	United States	30303
7	Emory Crawford Long Hospital	Atlanta	Georgia	United States	30308
8	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
9	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-3785
10	Rush University Medical Center	Chicago	Illinois	United States	60612
11	Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital	Downers Grove	Illinois	United States	60515-1500
12	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
13	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068-1174
14	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
15	Cancer Institute at St. John's Hospital	Springfield	Illinois	United States	62702
16	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana	United States	46016
17	St. Vincent Oncology Center	Indianapolis	Indiana	United States	46260
18	Cancer Center at Ball Memorial Hospital	Muncie	Indiana	United States	47303-3499
19	Menorah Medical Center	Overland Park	Kansas	United States	66209
20	Shawnee Mission Medical Center	Shawnee Mission	Kansas	United States	66204
21	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40292
22	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
23	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
24	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
25	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
26	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
27	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
28	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
29	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
30	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
31	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
32	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
33	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
34	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
35	North Kansas City Hospital	Kansas City	Missouri	United States	64116
36	Parvin Radiation Oncology	Kansas City	Missouri	United States	64116
37	CCOP - Kansas City	Kansas City	Missouri	United States	64131
38	Research Medical Center	Kansas City	Missouri	United States	64132
39	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
40	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
41	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
42	Renown Institute for Cancer at Renown Regional Medical Center	Reno	Nevada	United States	89502
43	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire	United States	03431
44	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
45	Monmouth Medical Center	Long Branch	New Jersey	United States	07740-6395
46	Saint Peter's University Hospital	New Brunswick	New Jersey	United States	08901
47	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
48	Beth Israel Medical Center - Petrie Division	New York	New York	United States	10003-3803
49	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
50	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
51	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
52	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
53	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
54	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
55	Hematology Oncology Center	Elyria	Ohio	United States	44035
56	Lima Memorial Hospital	Lima	Ohio	United States	45804
57	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
58	St. Luke's Hospital	Maumee	Ohio	United States	43537
59	Fisher-Titus Medical Center	Norwalk	Ohio	United States	44857
60	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
61	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
62	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
63	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
64	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
65	Toledo Hospital	Toledo	Ohio	United States	43606
66	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
67	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
68	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
69	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
70	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
71	Fulton County Health Center	Wauseon	Ohio	United States	43567
72	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
73	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
74	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
75	Adventist Medical Center	Portland	Oregon	United States	97216
76	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
77	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
78	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97239
79	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
80	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
81	AnMed Cancer Center	Anderson	South Carolina	United States	29621
82	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
83	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
84	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
85	American Fork Hospital	American Fork	Utah	United States	84003
86	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
87	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
88	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
89	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
90	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
91	LDS Hospital	Salt Lake City	Utah	United States	84103
92	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
93	Norris Cotton Cancer Center - North	Saint Johnsbury	Vermont	United States	05819
94	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
95	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
96	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
97	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
98	McGill Cancer Centre at McGill University	Montreal	Quebec	Canada	H2W 1S6

Sponsors and Collaborators

• Radiation Therapy Oncology Group
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radiation Therapy Oncology Group
• ClinicalTrials.gov Identifier: NCT00898300
• Other Study ID Numbers: RTOG 0514; CDR0000460036
• First Posted: May 12, 2009
• Last Update Posted: Nov 13, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Radiation Therapy Oncology Group: 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; 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
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Nov 13, 2015